HDL EZ-TZ3 Cholesterol Reagent Kit
FDA 510(k) K840677 · Preventive Diagnostics Corp.
510(k) numberK840677
Submission
- Device name
- HDL EZ-TZ3 Cholesterol Reagent Kit
- Applicant
- Preventive Diagnostics Corp.
Mchenry, IL, US - Received
- February 15, 1984
- Decision date
- April 13, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LBS – Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1475
- Specialty
- Clinical Chemistry
Other 510(k)s with product code LBS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K162593 | HDL-Cholesterol Gen.4LBS · Traditional | Roche Diagnostics Operations (Rdo) | 10/19/2016SE |
| K153435 | Direct HDL Cholesterol (HDL)LBS · Traditional | Randox Laboratories, Ltd. | 01/08/2016SE |
| K132711 | Carolina Liquid Chemistries HDL Cholesterol ReagentLBS · Traditional | Carolina Liquid Chemistries Corp. | 05/08/2014SE |
| K120609 | Vitros Chemistry Products DHDL SlidesLBS · Special | Ortho-Clinical Diagnostics, Inc. | 09/07/2012SE |
| K111516 | NMR Lipoprofile (R) Test and NMR ProfilerLBS · Traditional | Liposcience, Inc. | 09/27/2011SE |
| K103747 | Elitech Clincal Systems Cholesterol HDL SL 2G, HDL 2G Calibrator, LDL SL 2G, LDL 2G…LBS · Traditional | Elitechgroup Seppim S.A.S. | 08/31/2011SE |
| K111036 | Easyra HDL Reagent; Easyra LDL Reagent; Easyra Chol Reagent; Easyra Trig ReagentLBS · Traditional | Medica Corporation | 07/12/2011SE |
| K100550 | Poly-Chem 90 Direct HDL Cholesterol, Poly-Chem 90 Direct LDL Cholesterol, Poly-Chem 90…LBS · Traditional | Polymedco, Inc. | 09/28/2010SE |
| K100010 | HDL Cholesterol (HDLX) AssayLBS · Traditional | Beckman Coulter, Inc. | 05/14/2010SE |
| K080125 | Apolowako T-Cho, Hdl-C, TG and Analyzer, Models 993-23501, 999-23601, 995-23701 and…LBS · Traditional | Wako Chemicals USA, Inc. | 07/18/2008SE |
More from Wako Chemicals USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K840676 | PDC HDL Ez-Sep Cholesterol ReagentLBS · Traditional | 04/04/1984SE |
| K840991 | Preserv Buffered Glycerol SalineJTW · Traditional | 03/23/1984SE |
| K840990 | Preserv Cary Blair Transport PackJTW · Traditional | 03/23/1984SE |
| K840968 | Preserv Transport & Culture PackJTW · Traditional | 03/23/1984SE |
| K840278 | HDL Cholesterol Controls-LevelsJIX · Traditional | 03/23/1984SE |
| K840220 | HDL Cholesterol Aqueous StandardsJIS · Traditional | 03/23/1984SE |
| K840219 | Triglyceride/Cholesterol AqueousJIX · Traditional | 03/23/1984SE |
| K840218 | Triglyceride Aqueous StandardsJIT · Traditional | 03/23/1984SE |
| K840217 | Cholesterol Aqueous StandardJIS · Traditional | 03/23/1984SE |
| K840189 | Total Cholesterol Reagent SetCHH · Traditional | 03/23/1984SE |
Questions and answers
When was HDL EZ-TZ3 Cholesterol Reagent Kit cleared by the FDA?
HDL EZ-TZ3 Cholesterol Reagent Kit (K840677) received a 510(k) decision of Substantially Equivalent on April 13, 1984, 58 days after the submission was received.
What is the product code of K840677?
The FDA product code is LBS – Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl, a Class I (low risk) device regulated under 21 CFR 862.1475.