Enzymatic Esterase--Oxidase, Cholesterol
FDA product code CHH · Class I (low risk) · 21 CFR 862.1175 · Clinical Chemistry
230510(k) clearances
0PMA approvals
22recalls
Manufacturers
- Em Diagnostic Systems, Inc. 10
- Cholestech Corp. 10
- Beckman Instruments, Inc. 7
- Boehringer Mannheim Corp. 7
- Polymer Technology Systems, Inc. 7
- Abbott Laboratories 5
- Emd Chemicals, Inc. 5
- American Monitor Corp. 5
- Macomb Chemical Co. 4
- Sclavo, Inc. 4
- J. D. Assoc. 4
- Sigma Chemical Co. 4
- Abaxis, Inc. 3
- Sigma Diagnostics, Inc. 3
- Wako Chemicals USA, Inc. 3
- Chemtrak, Inc. 3
- Alfa Wassermann Diagnostic Technologies, Inc. 3
- Trace Scientific , Ltd. 3
- Data Medical Associates, Inc. 3
- Roche Diagnostic Systems, Inc. 3
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251091 | LipidsCHH · Traditional | Truvian Health | 12/30/2025SE |
| K232404 | CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDESCHH · Traditional | Medicon Hellas S.A | 08/09/2024SE |
| K203597 | Cholesterol2CHH · Traditional | Abbott Ireland Diagnostics Division | 06/30/2022SE |
| K190490 | VITROS XT Chemistry Products TRIG-CHOL SlidesCHH · Traditional | Ortho-Clinical Diagnostics, Inc. | 03/27/2019SE |
| K181373 | Extended Lipid Panel AssayCHH · Traditional | Laboratory Corporation of America Holdings | 10/18/2018SE |
| K180504 | Mission Lipid Panel Monitoring SystemCHH · Special | ACON Laboratories, Inc. | 03/28/2018SE |
| K163406 | Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring SystemCHH · Traditional | ACON Laboratories, Inc. | 07/11/2017SE |
| K151545 | CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System…CHH · Traditional | Polymer Technology Systems, Inc. | 12/22/2016SE |
| K150654 | CholesterolCHH · Traditional | Randox Laboratories, Ltd. | 09/29/2015SE |
| K132031 | Afinion Lipid Panel and Afinion Lipid Panel ControlCHH · Traditional | Axis-Shield Poc AS | 03/21/2014SE |
| K130200 | Piccolo Total Cholesterol - Capillary Test SystemCHH · Traditional | Abaxis, Inc. | 02/15/2013SE |
| K122757 | Ace Cholesterol Reagent, Ace Hdl-C Reagent, Ace Ldl-C Reagent, Ace Triglycerides ReagentCHH · Traditional | Alfa Wassermann Diagnostic Technologies, Inc. | 10/05/2012SE |
| K120202 | Eon Cholesterol ReagentCHH · Traditional | Vital Diagnostics Pty., Ltd. | 07/27/2012SE |
| K113262 | Ace Cholesterol Reagent, Ace Hdl-C Reagent, Ace Ldl-C Reagent-C, Ace-Trislycerides ReagentCHH · Traditional | Alfa Wassermann Diagnostic Technologies, Inc. | 07/03/2012SE |
| K112538 | Ace Cholesterol Reagent, Ace Hdl-C Reagent, Ace Ldl-C Reagent, Ace Triglycerides ReagentCHH · Traditional | Alfa Wassermann Diagnostic Technologies, Inc. | 03/29/2012SE |
| K111753 | Hitachi Clinical Analyzer S Test Reagent Catridge for: Cholestrol, HDL, LDL, and…CHH · Traditional | Hitachi Chemical Diagnostics, Inc. | 12/14/2011SE |
| K091413 | S-Test Cholesterol (Cho), Model RC0009, S-Test HDL Cholesterol (HDL), Model RC0015…CHH · Traditional | Alfa Wassermann, Inc. | 10/26/2009SE |
| K080623 | Cholesterol Oxidase Jase, and Glycerol Inase Triglycerides, Model NaCHH · Traditional | Jas Diagnostics, Inc. | 11/17/2008SE |
| K072249 | Easyra Cholesterol Reagent; Easyra Calcium Reagent ReagentCHH · Traditional | Medica Corp. | 02/20/2008SE |
| K071593 | PTS Panels Chol+Hdl Panel Test StripsCHH · Special | Polymer Technology Systems, Inc. | 10/15/2007SE |
| K062026 | Vap-Nt Cholesterol TestCHH · Traditional | Atherotech, Inc. | 03/06/2007SE |
| K051376 | Accuchek Instant Plus Dual Testing System, Accuchek Instant Plus Cholesterol, Accuchek…CHH · Traditional | Roche Diagnostics | 08/23/2005SE |
| K042443 | Spotchem HDL, Total Cholesterol and Triglyceride Reagent Tests and PanelCHH · Traditional | Arkray, Inc. | 11/24/2004SE |
| K031824 | Cobas Integra Cholesterol Gen. 2CHH · Special | Roche Diagnostics Corp. | 07/09/2003SE |
| K023642 | Piccolo Total Cholesterol Test SystemCHH · Traditional | Abaxis, Inc. | 01/24/2003SE |
| K023558 | PTS Panels Lipid Panel Test StripsCHH · Special | Polymer Technology Systems, Inc. | 11/15/2002SE |
| K022898 | PTS Panels Lipid Panel Test StripsCHH · Special | Polymer Technology Systems, Inc. | 09/24/2002SE |
| K013173 | Bioscanner Plus; Lipid Panel Test StripsCHH · Special | Polymer Technology Systems, Inc. | 10/22/2001SE |
| K011970 | Biosafe Cholesterol Profile Blood Collection and Transport SystemCHH · Traditional | Biosafe Laboratories, Inc. | 09/26/2001SE |
| K001032 | Rlp-Cholesterol Immunoseparation AssayCHH · Traditional | Otsuka Pharmaceutical Co., Ltd. | 07/24/2000SE |
| K000610 | Resolution Cholesterol MonitorCHH · Traditional | Lifestream Technologies, Inc. | 07/21/2000SE |
| K000900 | Atac Pak Cholesterol Reagent and Atac Callibrator KitsCHH · Traditional | Elan Holdings, Inc. | 05/02/2000SE |
| K993096 | Privalink Software Accessory to the Lifestream Cholesterol MonitorCHH · Traditional | Lifestream Technologies, Inc. | 12/20/1999SE |
| K992803 | Sigma Diagnostics Infinity Cholesterol Reagent, Models 401-25, 401-100P, 401-500P…CHH · Traditional | Sigma Diagnostics, Inc. | 09/13/1999SE |
| K992132 | Cholesite Test SystemCHH · Traditional | Gds Technology, LLC | 08/20/1999SE |
| K991083 | RLP Cholesterol Immunoseparation AssayCHH · Traditional | Otsuka Pharmaceutical Co., Ltd. | 08/20/1999SE |
| K990688 | MTM Bioscanner C Test StripsCHH · Traditional | Polymer Technology Systems, Inc. | 06/24/1999SE |
| K981345 | Cholestron Pro II Cholesterol TestCHH · Traditional | Lifestream Diagnostics, Inc. | 10/01/1998SE |
| K982469 | Hichem Cholesterol Reagent KitCHH · Traditional | Elan Pharma, Inc. | 08/19/1998SE |
| K981181 | Ena-C-T Total Cholesterol Test Model F 20000, (Physician Directed Use)CHH · Traditional | Actimed Laboratories, Inc. | 08/03/1998SE |
| K982118 | Careside AnalyzerCHH · Traditional | Exigent Diagnostics, Inc. | 07/24/1998SE |
| K981493 | MTM Bioscanner C Test Strips Model Number Bsa 200, Bsa 210, Bsa 220CHH · Traditional | Polymer Technology Systems, Inc. | 07/22/1998SE |
| K981652 | CholCHH · Traditional | Abbott Laboratories | 06/29/1998SE |
| K981476 | CholCHH · Traditional | Abbott Laboratories | 06/25/1998SE |
| K980667 | Infinity Cholesterol Reagent (Procedure No. 401)CHH · Traditional | Sigma Diagnostics, Inc. | 04/21/1998SE |
| K973284 | Cobas Integra Hdl-Cholesterol DirectCHH · Traditional | Roche Diagnostic Systems, Inc. | 12/18/1997SE |
| K972853 | Cholesterol Rapid Liquid ReagentCHH · Traditional | Reagents Applications, Inc. | 09/24/1997SE |
| K971072 | Cholesterol ReagentCHH · Traditional | Derma Media Lab., Inc. | 06/20/1997SE |
| K971505 | Synchron Systems Cholesterol (Chol) ReagentCHH · Traditional | Beckman Instruments, Inc. | 06/11/1997SE |
| K964660 | Paramax Cholesterol ReagentCHH · Traditional | Dade Intl., Inc. | 06/04/1997SE |
| K971345 | Chol or CholesterolCHH · Traditional | Carolina Liquid Chemistries Corp. | 05/29/1997SE |
| K962890 | Cholesterol-Incorporating Dynamic Stab Tech (DST)CHH · Traditional | Trace Scientific , Ltd. | 09/27/1996SE |
| K960377 | Ena-C-T Total Cholesterol TestCHH · Traditional | Actimed Laboratories, Inc. | 05/02/1996SE |
| K944458 | Accu-Chek Instant Plus Choloesterol TestCHH · Traditional | Boehringer Mannheim Corp. | 03/06/1996SE |
| K946161 | Dma Total Cholesterol ProcedureCHH · Traditional | Data Medical Associates, Inc. | 08/23/1995SE |
| K952127 | Boehringer Mannheim Cholesterol AssayCHH · Traditional | Boehringer Mannheim Corp. | 07/20/1995SE |
| K950164 | Piccolo(Tm) Primary Health Panel Reagent RotorCHH · Traditional | Abaxis, Inc. | 04/13/1995SE |
| K943599 | Chem Trak AccumeterCHH · Traditional | Chemtrak, Inc. | 03/21/1995SE |
| K946067 | Total Cholesterol, HDL Cholesterol, Triglycerides and Glucose PanelCHH · Traditional | Cholestech Corp. | 02/22/1995SE |
| K946066 | Total Cholesterol, HDL Cholesterol and Glucose PanelCHH · Traditional | Cholestech Corp. | 02/22/1995SE |
| K946065 | Total Cholesterolm HDL Cholesterol and Triglycerides PanelCHH · Traditional | Cholestech Corp. | 02/22/1995SE |
| K946064 | Total Cholesterol CassetteCHH · Traditional | Cholestech Corp. | 02/22/1995SE |
| K946063 | Total Cholesterol and HDL Cholesterol PanelCHH · Traditional | Cholestech Corp. | 02/22/1995SE |
| K943027 | Cholesterol QvetCHH · Traditional | Prisma Systems | 01/27/1995SE |
| K941573 | Roche ReagentCHH · Traditional | Roche Diagnostic Systems, Inc. | 10/31/1994SE |
| K923504 | Cholesterol Enzymatic EndpointCHH · Traditional | Randox Laboratories, Ltd. | 01/10/1994SE |
| K935136 | Cholesterol (Chol) Test Item No. 65410CHH · Traditional | Em Diagnostic Systems, Inc. | 12/16/1993SE |
| K934046 | Beckman Cholesterol ReagentCHH · Traditional | Beckman-Diagnostic Systems Group | 10/28/1993SE |
| K914432 | Accumeter(R) Cholesterol Self-TestCHH · Traditional | Chemtrak, Inc. | 03/02/1993SE |
| K925603 | Olympus Cholesterol ReagentCHH · Traditional | Olympus Corp. | 02/08/1993SE |
| K924508 | Cholesterol Test Item# 42374/93, 42322/R1CHH · Traditional | Em Diagnostic Systems, Inc. | 01/28/1993SE |
| K922231 | Olympus Cholesterol ReagentCHH · Traditional | Olympus Corp. | 11/18/1992SE |
| K923733 | Cholesterol TestCHH · Traditional | Em Diagnostic Systems, Inc. | 10/26/1992SE |
| K923128 | King Diagnostics Cholesterol ReagentCHH · Traditional | King Diagnostics, Inc. | 09/09/1992SE |
| K922612 | Cholestech Lipid Monitoring System, Total CholesteCHH · Traditional | Cholestech Corp. | 06/24/1992SE |
| K914160 | Cholesterol Regeant SetCHH · Traditional | Tech Intl. Co. | 01/30/1992SE |
| K913565 | Abbott Quickstart Cholesterol TestCHH · Traditional | Em Diagnostic Systems, Inc. | 12/18/1991SE |
| K914469 | Cholestech Lipid Monit Syst, Total Chol/Trig PanelCHH · Traditional | Cholestech Corp. | 10/30/1991SE |
| K912499 | King Diagnostics Cholesterol Reagent Strip TestCHH · Traditional | King Diagnostics, Inc. | 09/27/1991SE |
| K912212 | Proact Cholesterol SystemsCHH · Traditional | Boehringer Mannheim Corp. | 08/28/1991SE |
| K911692 | Enzymatics, Inc., Total Cholesterol TestCHH · Traditional | Enzymatics C/O Burditt,Bowles,Radzius & Ruberry | 08/16/1991SE |
| K912136 | Cholestech Lipid Monitoring Sys.CHH · Traditional | Cholestech Corp. | 07/30/1991SE |
| K911578 | Cholestech L.D.X. Lipid Analyzer, ModificationCHH · Traditional | Cholestech Corp. | 05/15/1991SE |
| K905405 | Chemtrak Accumeter Cholesterol TestCHH · Traditional | Chemtrak, Inc. | 03/19/1991SE |
| K904031 | Chema Chol Cholesterol SystemCHH · Traditional | Texas Intl. Laboratories, Inc. | 03/11/1991SE |
| K905648 | CRP Lipid Reagent Test PackCHH · Traditional | Cirrus Diagnostics, Inc. | 03/06/1991SE |
| K910240 | Cholestat (TM) Whole Blood Cholesterol TestCHH · Traditional | Crystal Diagnostics, Inc. | 02/26/1991SE |
| K905145 | Eclipse Ica CholesterolCHH · Traditional | Biotope, Inc. | 02/26/1991SE |
| K903126 | Cholestat(Tm) Whole Blood Cholesterol TestCHH · Traditional | Crystal Diagnostics, Inc. | 12/26/1990SE |
| K903015 | Synermed Cholesterol Reagent KitCHH · Traditional | Synermed, Inc. | 10/01/1990SE |
| K902678 | Liquid Stable Cholesterol Reagent KitCHH · Traditional | Trace Scientific , Ltd. | 09/25/1990SE |
| K902098 | Cholesterol (Rate) ReagentCHH · Traditional | Sigma Chemical Co. | 08/09/1990SE |
| K901900 | L.D.X Lipid Monitoring SystemCHH · Traditional | Cholestech Corp. | 07/24/1990SE |
| K896467 | Satellite C Blood Cholesterol Monitoring SystemCHH · Traditional | Medisense, Inc. | 06/12/1990SE |
| K900850 | Emds Cholesterol (Cho), Item Numbers 65410CHH · Traditional | Em Diagnostic Systems, Inc. | 03/29/1990SE |
| K897162 | Coulter Cholesterol ReagentCHH · Traditional | Coulter Electronics, Inc. | 03/29/1990SE |
| K897036 | Immunotech Cholesterol TestCHH · Traditional | Immunotech Corp. | 03/06/1990SE |
| K896239 | Cobas Ready Cholesterol ReagentCHH · Traditional | Roche Diagnostic Systems, Inc. | 02/16/1990SE |
| K895951 | Cholesterol Test KitCHH · Traditional | Elite Technology, Inc. | 02/16/1990SE |
| K896073 | Cholesterol, Universal EtCHH · Traditional | Enzyme Technology, Inc. | 12/12/1989SE |
| K895158 | Vision Whole Blood HDL CholesterolCHH · Traditional | Abbott Laboratories | 10/02/1989SE |
| K893916 | Emds Cholesterol (Cho), Item Number 65410CHH · Traditional | Em Diagnostic Systems, Inc. | 08/28/1989SE |
| K893479 | Cholesterol Reagent SetCHH · Traditional | American Monitor Corp. | 06/19/1989SE |
| K891922 | Amresco Cholesterol Reagents, Prod. # 7325CHH · Traditional | American Research Products Co. | 06/16/1989SE |
| K892238 | Cla 200 Chempro(R) Lipid AnalyzerCHH · Traditional | Johnson & Johnson Professionals, Inc. | 06/07/1989SE |
| K890334 | Total Cholesterol ReagentCHH · Traditional | Alpkem Corp. | 05/03/1989SE |
| K890267 | Quikread Chem. Analyzer & Choles. for Serum/PlasmaCHH · Traditional | Photec Diagnostics, Inc. | 04/26/1989SE |
| K890027 | Quikread Chem. Analyzer & Choles. for Whole BloodCHH · Traditional | Photec Diagnostics, Inc. | 04/26/1989SE |
| K890990 | Extend Intended Use for Enzyme Rinse ConcentrateCHH · Traditional | Hichem Diagnostics | 04/10/1989SE |
| K884757 | Clinistat Cholesterol Reagent TestCHH · Traditional | Heraeus Kulzer, Inc. | 03/10/1989SE |
| K885023 | Cholesterol Test Item Number: SR1011CHH · Traditional | Em Diagnostic Systems, Inc. | 02/17/1989SE |
| K883543 | Hdl-Cholesterol Precipitating ReagentCHH · Traditional | Medical Analysis Systems, Inc. | 12/16/1988SE |
| K880723 | Dimension Whole Blood CholesterolCHH · Traditional | Technimed, Inc. | 11/08/1988SE |
| K883844 | Hi Chem Kinetic Cholesterol Reagent #88218CHH · Traditional | Hichem Diagnostics | 10/31/1988SE |
| K864159 | Solid Phase Deter Serum Cholesterol FR Whole BloodCHH · Traditional | Chem-Elec, Inc. | 06/10/1988SE |
| K880237 | CholesterolCHH · Traditional | Tech-Neal Scientific, Inc. | 04/28/1988SE |
| K880311 | Wako(Tm) Autokit CholesterolCHH · Traditional | Wako Chemicals USA, Inc. | 03/01/1988SE |
| K875131 | (SKD) Cholesterol Test KitCHH · Traditional | Smithkline Diagnostics, Inc. | 03/01/1988SE |
| K872930 | Biotrol Cholesterol Enzymatique ColorCHH · Traditional | Biotrol, USA, Inc. | 08/21/1987SE |
| K872575 | HDL Cholesterol ReagentCHH · Traditional | Sigma Chemical Co. | 07/16/1987SE |
| K872295 | Cholesterol ReagentCHH · Traditional | Sigma Diagnostics, Inc. | 07/16/1987SE |
| K871676 | Enzymatic Cholesterol Reagent SetCHH · Traditional | Michclone Associates, Inc. | 05/18/1987SE |
| K870928 | Cholesterol (Total) Analysis ProductsCHH · Traditional | Electro-Nucleonics Laboratories, Inc. | 04/22/1987SE |
| K871260 | Cholesterol DeterminationCHH · Traditional | Biochemical Trade, Inc. | 04/13/1987SE |
| K870828 | Intersect Systems Enzymatic Cholesterol ReagentCHH · Traditional | Intersect Systems, Inc. | 03/13/1987SE |
| K870407 | Easy-Test Cholesterol(Chol) Number 16607CHH · Traditional | Em Diagnostic Systems, Inc. | 03/04/1987SE |
| K863103 | Peg 6,000CHH · Traditional | J. D. Assoc. | 01/13/1987SE |
| K864081 | U.S. Diagnostics Serum Cholesterol TestCHH · Traditional | U. S. Diagnostics, Inc. | 12/04/1986SE |
| K863927 | CholesterolCHH · Traditional | Tech-Co, Inc. | 11/24/1986SE |
| K863252 | Cholesterol ProcedureCHH · Traditional | Data Medical Associates, Inc. | 09/29/1986SE |
| K863062 | Cholesterol-E (Total)CHH · Traditional | J. D. Assoc. | 09/25/1986SE |
| K863064 | Cholesterol-E (Free)CHH · Traditional | J. D. Assoc. | 09/11/1986SE |
| K863063 | Cholesterol-E Fast (Total)CHH · Traditional | J. D. Assoc. | 09/09/1986SE |
| K862707 | Emds(Tm) Cholesterol Testpack, # 67685/95CHH · Traditional | Em Diagnostic Systems, Inc. | 08/19/1986SE |
| K862507 | Fast Cholesterol (Total Cholesterol Test)CHH · Traditional | Sclavo, Inc. | 07/16/1986SE |
| K861659 | Cholesterol ProcedureCHH · Traditional | Data Medical Associates, Inc. | 06/13/1986SE |
| K861700 | Dimension (TM) Clinical Chemistry SystemCHH · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 06/11/1986SE |
| K860717 | Enzymatic Cholesterol Reagent (Single Vial)CHH · Traditional | Trace Scientific , Ltd. | 04/11/1986SE |
| K855028 | Total Cholesterol Reagent SetCHH · Traditional | Sterling Diagnostics, Inc. | 01/28/1986SE |
| K854426 | Kodak Ektachem HDL Cholesterol KitCHH · Traditional | Eastman Kodak Company | 01/17/1986SE |
| K855187 | Enzymatic Cholestrol Reagent SetCHH · Traditional | Technostics Intl. | 01/14/1986SE |
| K854179 | In-Vitro Test for the Determination of CholesterolCHH · Traditional | Clinical Data, Inc. | 11/25/1985SE |
| K853854 | Astra Systems Cholesterol ReagentCHH · Traditional | Beckman Instruments, Inc. | 10/28/1985SE |
| K853871 | Qca Enzymatic CholesterolCHH · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 10/04/1985SE |
| K852863 | Cholesterol MethodCHH · Traditional | Catachem, Inc. | 07/23/1985SE |
| K850390 | Cholesterol Test SystemCHH · Traditional | Hans J. Brouwers & Assoc. | 07/09/1985SE |
| K852009 | T-Cho ReagentCHH · Traditional | Alpkem Corp. | 05/30/1985SE |
| K844655 | Peridochrom Cholesterol High PerformanceCHH · Traditional | Boehringer Mannheim Corp. | 01/07/1985SE |
| K844242 | Cholesterol Reagent for Demand AnalyzerCHH · Traditional | Advanced Biomedical Methods, Inc. | 01/03/1985SE |
| K843510 | Pda CholesterolCHH · Traditional | Abbott Laboratories | 09/28/1984SE |
| K843222 | Enzymatic Cholesterol KitCHH · Traditional | Livonia Diagnostics, Inc. | 09/28/1984SE |
| K843327 | Systemate Cholesterol 67222CHH · Traditional | Em Diagnostic Systems, Inc. | 09/14/1984SE |
| K842160 | Cholesterol Asssay KitCHH · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 08/17/1984SE |
| K842320 | TDX Rea CholesterolCHH · Traditional | Abbott Laboratories | 08/15/1984SE |
| K842441 | Axiom Stable II Cholesterol TestCHH · Traditional | Axiom, Inc. | 07/25/1984SE |
| K841182 | Multiple Chem. Module for AnalysisCHH · Traditional | Beckman Instruments, Inc. | 05/09/1984SE |
| K841053 | Cholesterol Reagent Set EnzymaticCHH · Traditional | Medical Specialties, Inc. | 05/01/1984SE |
| K840776 | Paramax Cholesterol ReagentCHH · Traditional | American Dade | 04/04/1984SE |
| K840368 | Durazyme CholesterolCHH · Traditional | American Monitor Corp. | 03/30/1984SE |
| K840189 | Total Cholesterol Reagent SetCHH · Traditional | Preventive Diagnostics Corp. | 03/23/1984SE |
| K832780 | Flow-Pac Sholesterol Reagent SetCHH · Traditional | American Research Products Co. | 10/14/1983SE |
| K832158 | Cholesterol High Performance-KCHH · Traditional | Boehringer Mannheim Corp. | 08/16/1983SE |
| K831863 | Cholesterol-Enzymatic Reagent SetCHH · Traditional | Stanbio Laboratory | 07/22/1983SE |
| K831700 | Multichem Enzymatic Cholesterol SysCHH · Traditional | Simmler, Inc. | 07/19/1983SE |
| K831687 | Wako Cholesterol CiiCHH · Traditional | Wako Chemicals USA, Inc. | 07/18/1983SE |
| K830761 | Wako Free Cholesterol C TestCHH · Traditional | Wako Chemicals USA, Inc. | 04/18/1983SE |
| K830239 | Ultra Chem Enzymatic Cholesterol OxidaCHH · Traditional | Emd Chemicals, Inc. | 04/05/1983SE |
| K830309 | Ultra Chem Enzymatic Cholesterol OxidaseCHH · Traditional | Emd Chemicals, Inc. | 02/28/1983SE |
| K823784 | Enzymatic Cholesterol (ColorimetricCHH · Traditional | Analytical & Research Chemicals, Inc. | 01/14/1983SE |
| K823500 | Cholesterol ReagentCHH · Traditional | Ac Biochemical Laboratories, Inc. | 12/30/1982SE |
| K823354 | Ultrachem Enzymatic Cholesterol OxidaseCHH · Traditional | Emd Chemicals, Inc. | 12/22/1982SE |
| K823302 | Cholesterol Chod-Pap TestCHH · Traditional | Boehringer Mannheim Corp. | 12/09/1982SE |
| K823187 | Cholesterol High Sensit. Reagent EnzymCHH · Traditional | Rai, Inc. | 11/22/1982SE |
| K822417 | New Enzymatic Single Reagent Free Chol.CHH · Traditional | Sclavo, Inc. | 10/21/1982SE |
| K822418 | Ultrachem Enzymatic Chol. OxidaseCHH · Traditional | Emd Chemicals, Inc. | 09/14/1982SE |
| K821441 | Enzymatic Cholesteral Oxidase #650550CHH · Traditional | Emd Chemicals, Inc. | 06/01/1982SE |
| K821105 | Cholestezyme-V EikenCHH · Traditional | Syn-Kit, Inc. | 05/05/1982SE |
| K820951 | Enzymatic Cholesterol KitCHH · Traditional | Anco Medical Reagents & Assoc. | 04/26/1982SE |
| K820950 | Total Cholesterol Reagent SetCHH · Traditional | Sterling Biochemical, Inc. | 04/26/1982SE |
| K820473 | Enzymatic Cholesterol Reagent SystemCHH · Traditional | American Monitor Corp. | 03/11/1982SE |
| K820263 | Kodak Ektachem Clinical Chemistry SlidesCHH · Traditional | Eastman Kodak Company | 02/18/1982SE |
| K813039 | Ultrachem E-Chol, Item #65025CHH · Traditional | Harleco | 11/10/1981SE |
| K812293 | Centrichem Cholesterol Reagent & CalibraCHH · Traditional | Baker Diagnostics | 08/31/1981SE |
| K812100 | SeralyzerCHH · Traditional | Miles Laboratories, Inc. | 08/12/1981SE |
| K812091 | Fast Choles-CinetCHH · Traditional | Sclavo, Inc. | 08/12/1981SE |
| K811760 | Cholesterol DeterminationCHH · Traditional | Biorent Diagnostic, Inc. | 07/10/1981SE |
| K810673 | Enzymatic CholesterolCHH · Traditional | Pointe Scientific, Inc., | 03/31/1981SE |
| K810405 | Cholesterol ReagentCHH · Traditional | Gilford Diagnostics | 02/26/1981SE |
| K803287 | Cholesterol Reagent EnzymaticCHH · Traditional | Rai, Inc. | 01/16/1981SE |
| K803254 | Liquid-Stat Reagent for Assay of Choles.CHH · Traditional | Beckman Instruments, Inc. | 01/09/1981SE |
| K802743 | Ames Sera-Pak Cholesterol Reagent KitCHH · Traditional | Miles Laboratories, Inc. | 12/10/1980SE |
| K801285 | Ysi Models 23C & 23CM HDL & Total CholesCHH · Traditional | Yellow Springs Instrument Co., Inc. | 07/28/1980SE |
| K801296 | Cobas Reagent for CholesterolCHH · Traditional | Roche Analytical Instruments, Inc. | 06/30/1980SE |
| K800765 | Centrifichem CholesterolCHH · Traditional | Union Carbide Corp. | 04/24/1980SE |
| K800457 | Liquid-Stat Liquid ReagentCHH · Traditional | Beckman Instruments, Inc. | 03/20/1980SE |
| K800199 | Linear Enzymatic Cholesterol SystemCHH · Traditional | Simmler, Inc. | 02/21/1980SE |
| K792509 | Aca High Density Lipoprotein Choles.CHH · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 01/11/1980SE |
| K792478 | Chem-Strate CholesterolCHH · Traditional | General Diagnostics | 12/27/1979SE |
| K791511 | Enzymatic Reagent Set, 4X250 Ml.CHH · Traditional | Macomb Chemical Co. | 09/04/1979SE |
| K790947 | Auto Enzymatic CholesterolCHH · Traditional | Macomb Chemical Co. | 06/28/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2085-2026 Class II | QUCARE Total Cholesterol in vitro diagnostic test REF: 6407The devices were distributed without required FDA premarket clearance or approval. | DFI Co., Ltd. | 04/02/2026Open, Classified |
| Z-1424-2022 Class II | Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum…Product fails to meet the performance claims quoted on the kit insert: Manual Procedure when calibrating… | Randox Laboratories Ltd. | 06/22/2022Terminated |
| Z-0399-2022 Class II | SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825Cholesterol Reagent may fail with Out of Calibration Range Low (OCR Low) and/or Back to Back (B/B) errors.… | Beckman Coulter Inc. | 11/10/2021Open, Classified |
| Z-0328-2022 Class II | RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma…When calibrating using the standard provided in the kit, the change in absorbance is lower than expected… | Randox Laboratories Ltd. | 11/01/2021Terminated |
| Z-2158-2019 Class III | Henry Schein Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number:…The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD… | Polymer Technology Systems, Inc. | 06/07/2019Terminated |
| Z-2157-2019 Class III | PTS Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 1710 Product…The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD… | Polymer Technology Systems, Inc. | 06/07/2019Terminated |
| Z-1372-2019 Class II | Lipid Panel test strips (as a component of smart bundles), REF 2729, also private…Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which… | Polymer Technology Systems, Inc. | 01/16/2019Terminated |
| Z-1371-2019 Class II | Lipid Panel test strips, REF 1710, also private labeled under Henry Schein as REF 570-0414Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which… | Polymer Technology Systems, Inc. | 01/16/2019Terminated |
| Z-2081-2017 Class II | Cholesterol Reagent(CHOL 2 x 300), Catalog No. 467825 Intended for quantitative…Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole… | Beckman Coulter Inc. | 04/03/2017Terminated |
| Z-0929-2017 Class III | Enzymatic Cholesterol (Trinder/COD-CEH) for IN VITRO DIAGNOSTIC USE in the quantitative…Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of… | Sterling Diagnostics, Inc. | 07/20/2016Terminated |
| Z-1933-2016 Class II | Cholesterol, Catalog No. OSR6x16 Product Usage:Cholesterol OSR6x16 is intended as a…Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results in the… | Beckman Coulter Inc. | 04/13/2016Terminated |
| Z-1651-2016 Class II | Advia Chemistry Assays - Cholesterol_2 concentrated and Cholesterol, LDL CholesterolSiemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone)… | Siemens Healthcare Diagnostics, Inc. | 03/17/2016Terminated |
| Z-0738-2016 Class II | The ABX PENTRA Cholesterol CP ref. A11A01634 is an in vitro diagnostic assay for…N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with… | Horiba Instruments Inc | 01/11/2016Terminated |
| Z-1921-2015 Class II | Cholesterol Gen.2. The cassette COBAS Integra Cholesterol Gen.2 (CHOL2) contains an in…Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of… | Roche Diagnostics Operations, Inc. | 05/07/2015Terminated |
| Z-1920-2015 Class II | Cholesterol CHOD-PAP. In vitro diagnostic reagent system intended for use on the Hitachi…Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of… | Roche Diagnostics Operations, Inc. | 05/07/2015Terminated |
| Z-1025-2015 Class II | Beckman Coulter, Cholesterol Assay, Catalog No. OSR6X16N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of acetaminophen… | Beckman Coulter Inc. | 12/15/2014Terminated |
| Z-0304-2014 Class II | VITROS Chemistry Products CHOL Slides packaged as 300 slides/pack catalog number 1669829…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | Ortho-Clinical Diagnostics | 06/12/2013Terminated |
| Z-0964-2012 | Alere Cholestech LDX Analyzer, Model Number: 10-004, 14-874, 14-875, in vitro diagnostic.Alere has identified that a bias on results for certain analytes tested on the Alere Cholestech LDX System… | Alere San Diego | 11/16/2010Terminated |
| Z-0711-2011 | Genzyme Diagnostics Total Serum Cholesterol Kit, IVD Catalog Number: 225-26 Intended…Cholesterol Reagent bottles labels reversed for R1 and R2 | Diagnostic Chemicals, Ltd. | 11/10/2010Terminated |
| Z-1136-2010 | PTS Panels Lipids Panel test strips for self-testing or professional use with CardioChek…Exhibits under-recovery of all analytes. | Polymer Technology Systems, Inc. | 06/05/2009Terminated |
| Z-0871-2010 | PTS Panels Cholesterol test strips for self-testing or professional use with CardioChek…The memory chip was coded with incorrect product information. | Polymer Technology Systems, Inc. | 04/02/2009Terminated |
| Z-0975-2010 | PTS Panels CHOL+HDL Panel test strips for professional use with CardioChek P-A analyzer…Extended expiration date; the product expired on February 12, 2009 but was labeled with a April 4, 2009… | Polymer Technology Systems, Inc. | 02/20/2009Terminated |