Phosphomolybdate (Colorimetric), Inorganic Phosphorus
FDA product code CEO · Class I (low risk) · 21 CFR 862.1580 · Clinical Chemistry
105510(k) clearances
0PMA approvals
8recalls
Manufacturers
- Em Diagnostic Systems, Inc. 10
- Harleco 5
- Abbott Laboratories 4
- American Research Products Co. 4
- Data Medical Associates, Inc. 3
- Olympus Corp. 3
- Sclavo, Inc. 2
- Diagnostic Chemicals, Ltd. (Usa) 2
- Instrumentation Laboratory CO 2
- Emd Chemicals, Inc. 2
- Reagents Applications, Inc. 2
- Eastman Kodak Company 2
- Gilford Diagnostics 1
- Diagnostic Solutions, Inc. 1
- Sandare Chemical Co., Inc. 1
- Volu Sol Medical Industries 1
- Seppim S.A.S. 1
- Gamma Enterprises, Inc. 1
- Mallinckrodt Critical Care 1
- Icn Pharmaceuticals, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K100263 | Elitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV SL ReagentsCEO · Traditional | Seppim S.A.S. | 05/06/2011SE |
| K072141 | S40 Clinical Analyzer, S Test Ip, S Test UaCEO · Traditional | Alfa Wassermann Diagnostic Technologies, Inc. | 06/24/2008SE |
| K041643 | Synchron Systems Phosphorus (PHS) ReagentCEO · Traditional | Beckman Coulter, Inc. | 08/18/2004SE |
| K030015 | Atac Pak Phosphorus ReagentCEO · Traditional | Elan Diagnostics | 03/07/2003SE |
| K022312 | Piccolo Phosphorus Test SystemCEO · Traditional | Abaxis, Inc. | 09/05/2002SE |
| K013095 | Wiener Lab.Fosfatemia UV, Models 1X100 ML Cat.N 1382321, 4X20 ML Cat.N 1009311CEO · Traditional | Wiener Laboratories Saic | 11/16/2001SE |
| K003912 | Phosphorus ReagentCEO · Traditional | Jas Diagnostics, Inc. | 02/21/2001SE |
| K003012 | Raichem Phosporus ReagentCEO · Special | Hemagen Diagnostics, Inc. | 10/25/2000SE |
| K991867 | Inorganic Phosphorus (Ip), Product No's, 112-01, 112-02CEO · Traditional | A.P. Total Care, Inc. | 08/02/1999SE |
| K983503 | Roche Diagnostics, Boehringer Mannheim Corporation Inorganic Phosphorus Reagent Catalog…CEO · Traditional | Boehringer Mannheim Corp. | 12/01/1998SE |
| K981769 | Hichem Phosphorus Reagent KitCEO · Traditional | Elan Pharma, Inc. | 06/29/1998SE |
| K981610 | Careside AnalyzerCEO · Traditional | Careside, Inc. | 06/25/1998SE |
| K981759 | PhosCEO · Traditional | Abbott Laboratories | 06/16/1998SE |
| K981118 | PhosCEO · Traditional | Abbott Laboratories | 06/12/1998SE |
| K974858 | Phosphorus-Sl Assay, Catalogue Number 117-10, 117-30CEO · Traditional | Diagnostic Chemicals , Ltd. | 01/30/1998SE |
| K974605 | Randox Inorganic PhosphorousCEO · Traditional | Randox Laboratories, Ltd. | 01/09/1998SE |
| K971363 | Synchron CX Systems Phosphorus ReagentCEO · Traditional | Carolina Liquid Chemistries Corp. | 04/21/1997SE |
| K955937 | Inorganic Phosphorus ReagentCEO · Traditional | Derma Media Lab., Inc. | 03/12/1996SE |
| K944768 | Olympus Inorganic Phosphorus ReagentCEO · Traditional | Olympus America, Inc. | 03/24/1995SE |
| K942960 | Phosphate QvetCEO · Traditional | Prisma Systems | 12/09/1994SE |
| K945322 | Phosphorus Test (Phos) Item Number 65416CEO · Traditional | Emd Chemicals, Inc. | 12/07/1994SE |
| K945368 | Phosphorus Test (Phos)CEO · Traditional | Emd Chemicals, Inc. | 12/02/1994SE |
| K935178 | Emds Phosphorous (Phos) TestCEO · Traditional | Em Diagnostic Systems, Inc. | 12/17/1993SE |
| K931835 | Olympus Reply Inorganic Phosphorous ReagentCEO · Traditional | Olympus Corp. | 09/08/1993SE |
| K932729 | Kodak Ektachem Clinical Chemistry Slides (Phos)CEO · Traditional | Eastman Kodak Company | 08/03/1993SE |
| K931361 | Il Test PhosphorusCEO · Traditional | Instrumentation Laboratory CO | 05/11/1993SE |
| K925057 | Olympus Inorganic Phosphorus ReagentCEO · Traditional | Olympus Corp. | 11/19/1992SE |
| K924470 | Two Part Inorganic Phosphorus TestCEO · Traditional | Em Diagnostic Systems, Inc. | 10/14/1992SE |
| K923764 | Systemate Phosphorus Test Technicon Ra 1000CEO · Traditional | Em Diagnostic Systems, Inc. | 09/22/1992SE |
| K923564 | Olympus Inorganic Phosphorus ReagentCEO · Traditional | Olympus Corp. | 08/18/1992SE |
| K915708 | Inorganic Phosphorus(Colorimetric) Reagent SetCEO · Traditional | Tech Intl. Co. | 01/22/1992SE |
| K912809 | Abbott Quickstart Phosphorus(Phos) Item #5A14CEO · Traditional | Em Diagnostic Systems, Inc. | 08/12/1991SE |
| K912569 | Synermed Phosphorus Reagent KitCEO · Traditional | Synermed, Inc. | 07/17/1991SE |
| K910296 | Phosphorus (Inorganic) Test SystemCEO · Traditional | Biochemical Trade, Inc. | 02/27/1991SE |
| K903696 | Olympus Inorganic PhosphorusCEO · Traditional | Em Diagnostic Systems, Inc. | 09/12/1990SE |
| K901964 | Phosphorus Reagents Prod Codes 7763/7764/7563/7463CEO · Traditional | American Research Products Co. | 05/31/1990SE |
| K901807 | Olympus Inorganic Phosphorus (2-REAGENT Modifica.)CEO · Traditional | Em Diagnostic Systems, Inc. | 05/02/1990SE |
| K901137 | Chem 1 Clinical Analyzer (Urine Inorganic Phospho)CEO · Traditional | Technicon Instruments Corp. | 04/12/1990SE |
| K900977 | Amresco Inorganic Phosphorus Product #4312500CEO · Traditional | American Research Products Co. | 04/11/1990SE |
| K900215 | Coulter Phosphorus ReagentCEO · Traditional | Coulter Corp. | 02/08/1990SE |
| K895999 | PhosphorusCEO · Traditional | American Monitor Corp. | 01/11/1990SE |
| K890773 | Hi Chem Inorganic Phosphorus Reagent Kit #88196CEO · Traditional | Hichem Diagnostics | 04/18/1989SE |
| K891218 | Iq/Qca PhosphorusCEO · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 03/22/1989SE |
| K885041 | Biotrol Inorganic PhosphorusCEO · Traditional | Biotrol, USA, Inc. | 01/30/1989SE |
| K884735 | Phosphorus Test (Phos) Item #65666CEO · Traditional | Em Diagnostic Systems, Inc. | 12/16/1988SE |
| K883962 | Roche Reagent for Inorganic PhosphorusCEO · Traditional | Roche Diagnostic Systems, Inc. | 11/29/1988SE |
| K881171 | Phosphorus (Inorganic)CEO · Traditional | Tech-Co, Inc. | 04/28/1988SE |
| K880676 | Inorganic Phosphorus Reagent SetCEO · Traditional | Tech-Neal Scientific, Inc. | 03/24/1988SE |
| K874577 | Kodak Ektachem DT Slides (Phos)CEO · Traditional | Eastman Kodak Company | 01/21/1988SE |
| K874472 | Inorganic PhosphorusCEO · Traditional | Catachem, Inc. | 12/22/1987SE |
| K873454 | Paramax Phosphorus ReagentCEO · Traditional | Baxter Healthcare Corp | 11/23/1987SE |
| K874153 | Easy-Test Phosphorus (Phos) Item No. 16687CEO · Traditional | Em Diagnostic Systems, Inc. | 11/04/1987SE |
| K874038 | Multichem Inorganic Phosphorous S0923CEO · Traditional | Simmler, Inc. | 10/28/1987SE |
| K870368 | Phosphorus Reagent-Direct UV Method W/O ReductionCEO · Traditional | Trace Scientific , Ltd. | 08/19/1987SE |
| K871321 | Flow-Pac Inorganic Phosphorus ReagentsCEO · Traditional | American Research Products Co. | 04/22/1987SE |
| K870776 | Raichem(Tm) Phosphorus Reagent, Rapid EndpointCEO · Traditional | Reagents Applications, Inc. | 03/13/1987SE |
| K863718 | Emds(Tm) Phosphorus (Phos) Testpacks, #67678/95CEO · Traditional | Em Diagnostic Systems, Inc. | 10/29/1986SE |
| K863088 | Abbott Spectrum Phosphorus ReagentCEO · Traditional | Abbott Laboratories | 09/25/1986SE |
| K863264 | Inorganic Phosphorus ProcedureCEO · Traditional | Data Medical Associates, Inc. | 09/11/1986SE |
| K863072 | FosforometerCEO · Traditional | J. D. Assoc. | 09/09/1986SE |
| K862834 | Model 115-16 Phosphorus (UV) Assay KitCEO · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 08/19/1986SE |
| K861661 | Inorganic Phosphorus ProcedureCEO · Traditional | Data Medical Associates, Inc. | 07/01/1986SE |
| K861968 | Amresco Flow Pac Inorganic Phosphrus Reagent SetCEO · Traditional | American Research Products Co. | 06/13/1986SE |
| K860628 | Inorganic Phosphorus Reagent SetCEO · Traditional | Sterling Diagnostics, Inc. | 03/14/1986SE |
| K855154 | Inorganic Phosphorus Reagent SetCEO · Traditional | Technostics Intl. | 01/14/1986SE |
| K854188 | In Vitro Test Determination of Inorganic PhosphoroCEO · Traditional | Clinical Data, Inc. | 11/25/1985SE |
| K850934 | PhosphorusCEO · Traditional | Dilab, Inc. | 06/25/1985SE |
| K852103 | Inorganic Phosphorus Liquid Stable Reagent InorganCEO · Traditional | Medical Analysis Systems, Inc. | 05/31/1985SE |
| K852003 | Ip Acid Reagent Ip Moly Bdate ReagentCEO · Traditional | Alpkem Corp. | 05/31/1985SE |
| K850986 | Date Chem Inorganic Phosphorous U.V. ProcedureCEO · Traditional | Data Medical Associates, Inc. | 04/01/1985SE |
| K850380 | Inorganic Phosphorous for Demand AnalyzerCEO · Traditional | Advanced Biomedical Methods, Inc. | 03/01/1985SE |
| K844316 | Raichem Phosphorus ReagentCEO · Traditional | Reagents Applications, Inc. | 01/03/1985SE |
| K844182 | Inorganic Phosphorus Reagent SetCEO · Traditional | Livonia Diagnostics, Inc. | 11/09/1984SE |
| K843330 | Systemate Phosphorus 67217CEO · Traditional | Em Diagnostic Systems, Inc. | 09/14/1984SE |
| K843177 | Inorganic Phosphorus TestCEO · Traditional | Sclavo, Inc. | 09/14/1984SE |
| K843030 | Inorganic Phosphorus Assay KitCEO · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 08/27/1984SE |
| K841181 | Astra Sys Inorganic Phosphorus ChemCEO · Traditional | Beckman Instruments, Inc. | 05/09/1984SE |
| K841061 | Phophorus Reagnet SetCEO · Traditional | Medical Specialties, Inc. | 05/01/1984SE |
| K840215 | Phosphorus Reagent SystemCEO · Traditional | Sclavo, Inc. | 03/19/1984SE |
| K833002 | Paramax Phosphorus ReagentCEO · Traditional | American Dade | 10/14/1983SE |
| K823691 | Phosphorus Reagent SetCEO · Traditional | Omega Medical Electronics | 01/07/1983SE |
| K823580 | Cobas Reagent for Inorganic PhosphorusCEO · Traditional | Hoffmann-La Roche, Inc. | 01/07/1983SE |
| K822470 | Psi Inorganic PhosphorusCEO · Traditional | Pointe Scientific, Inc., | 09/14/1982SE |
| K821874 | Ultrachem PhosCEO · Traditional | Harleco Diagnostics | 07/13/1982SE |
| K813400 | Inorganic Phosphorus Reagent SetCEO · Traditional | Anco Medical Reagents & Assoc. | 12/22/1981SE |
| K811749 | King Diagnostics Phosphorus TestCEO · Traditional | King Diagnostics, Inc. | 07/10/1981SE |
| K802159 | Ammonium Molybdate Inorganic PhosphorusCEO · Traditional | Panmed, Inc. | 10/10/1980SE |
| K800690 | Reagent for Determ. Inorganic/PhosphorusCEO · Traditional | Diagnostic Solutions, Inc. | 05/28/1980SE |
| K800297 | Sandare Fast 340 Phosphorous ProcedureCEO · Traditional | Sandare Chemical Co., Inc. | 03/05/1980SE |
| K792401 | Elvi Inorganic PhosphorousCEO · Traditional | Volu Sol Medical Industries | 12/07/1979SE |
| K791708 | Inorganic Phosphorus ReagentCEO · Traditional | Gilford Diagnostics | 09/24/1979SE |
| K790021 | Serum, Inorganic PhosphorousCEO · Traditional | Fisher Scientific Co., LLC | 02/15/1979SE |
| K781806 | Reagent System, Inorganic PhosphorusCEO · Traditional | Sigma Chemical Co. | 01/17/1979SE |
| K781000 | Phosphorus (Inorganic) Analysis ProductsCEO · Traditional | Abbott Laboratories | 12/04/1978SE |
| K772156 | Ultrachem Phosphorus, 64973CEO · Traditional | Harleco | 12/06/1977SE |
| K771835 | Inorganic PhosphorusCEO · Traditional | Gamma Enterprises, Inc. | 11/02/1977SE |
| K771848 | Phosphorus Test KitCEO · Traditional | Mallinckrodt Critical Care | 10/28/1977SE |
| K771477 | Multistat III Phosphorous TestCEO · Traditional | Instrumentation Laboratory CO | 09/12/1977SE |
| K770820 | Ultrachem Inorganic PhosphorusCEO · Traditional | Harleco | 07/11/1977SE |
| K770456 | Phosphorous, Inorganic, Tekpoint DirectCEO · Traditional | Icn Pharmaceuticals, Inc. | 05/03/1977SE |
| K761239 | Auto-Inorganic Phosphorus ReagentCEO · Traditional | Harleco | 12/29/1976SE |
| K761238 | Auto-Inorganic Phosphorus ReagentCEO · Traditional | Harleco | 12/29/1976SE |
| K760634 | Aca Phosphorus Analytical Test PackCEO · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 11/24/1976SE |
| K760990 | Inorganic Phosphorous ReagentCEO · Traditional | Worthington Biochemical Corp. | 11/16/1976SE |
| K760030 | Clinicard PhosphorusCEO · Traditional | Harleco | 09/13/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0071-2026 Class II | SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx…Specific SYNCHRON Systems Modular Chemistry Phosphorus (PHOSm REF 467868) reagent lots may fail calibration… | Beckman Coulter Inc. | 09/03/2025Open, Classified |
| Z-1832-2025 Class II | ORTHO CLINICAL DIAGNOSTICS INC VITROS PHOSPHORUS (60/CR 5CR/PK) ORCLNL REAGENT.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to… | Mckesson Medical-Surgical Inc. Corporate… | 04/24/2025Open, Classified |
| Z-0020-2014 Class II | Clinical Chemistry Phosphorus Reagent The Phosphorus assay is used for the quantitation…Reagent lots 64736UN12, 03991UN13, 51611UN13, 74805UN12, and 03992UN13 have incorrect expiration dates… | Abbott Laboratories, Inc | 08/12/2013Terminated |
| Z-0320-2014 Class II | VITROS Chemistry Products PHOS Slides packaged as 300 slides/pack catalog number 1513209…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | Ortho-Clinical Diagnostics | 06/12/2013Terminated |
| Z-1049-2013 Class II | Siemens Dimension(R) Phosphorus (PHOS) Flex(R) reagent cartridge (DF61) The Phosphorus…Siemens Healthcare Diagnostics has initiated a voluntary field action for Dimension(R) PHOS Flex(R) Reagent… | Siemens Healthcare Diagnostics, Inc. | 02/22/2013Terminated |
| Z-0743-2013 Class II | Alfa Wassermann System Diluent 750 mL Manufactured for Alfa Wassermann Diagnostic…Inorganic phosphorus assays using System Diluent Lot 155599 may not product acceptable calibration results. | Alfa Wassermann, Inc. | 10/10/2012Terminated |
| Z-2398-2010 | Clinical Chemistry Phosphorus assayProduct may give inaccurate results and aspiration errors with reagent configuration, including results… | Abbott Laboratories Inc. | 05/04/2010Terminated |
| Z-0722-2007 | Clinical Chemistry Phosphorus in vitro diagnostic, List Number: 7D71-30 and 7D71-20Patient results are falsely decreased by up to 15% at these levels: 1) Serum Plasma phosphorus greater than… | Abbott Laboratories Inc. | 01/30/2007Terminated |