Poly-Chem 90 Direct HDL Cholesterol, Poly-Chem 90 Direct LDL Cholesterol, Poly-Chem 90 Cholesterol, Poly-Chem 90 Triglyc
FDA 510(k) K100550 · Polymedco, Inc.
510(k) numberK100550
Submission
- Device name
- Poly-Chem 90 Direct HDL Cholesterol, Poly-Chem 90 Direct LDL Cholesterol, Poly-Chem 90 Cholesterol, Poly-Chem 90 Triglyc
- Applicant
- Polymedco, Inc.
Cortlandt Manor, NY, US - Received
- February 26, 2010
- Decision date
- September 28, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K073497 | HDL Cholesterol Reagent, Model 10211LBS · Traditional | Medica Corp. | 04/14/2008SE |
More from Medica Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K112408 | Poly-Chem 90 Ise ModuleCEM · Traditional | 11/04/2011SE |
| K110818 | Poly-Chem 90 Albumin, Bun, Calcium, Carbon Dioxide, Creatinine, and Total Protein TestsCIX · Traditional | 09/08/2011SE |
| K111143 | Poly-Chem 90 Total BilirubinCIG · Traditional | 09/01/2011SE |
| K090703 | Poly-Chem 90 GlucoseCFR · Traditional | 10/20/2009SE |
| K061944 | Poly-Chem CreatinineJFY · Traditional | 11/03/2006SE |
| K053553 | Nycocard U-Albumin and U-Albumin ControlDCF · Traditional | 03/09/2006SE |
| K041408 | Polymedco Oc Auto Micro 80 Fob TestOOX · Traditional | 10/21/2004SE |
| K041297 | Polymedco Oc Light Fobt TestKHE · Traditional | 08/12/2004SE |
| K033706 | Polymedco Homocysteine Test for the Poly-Chem and Hitachi Chemistry SystemsLPS · Traditional | 02/04/2004SE |
| K023654 | Glyca-Direct FructosamineLCP · Traditional | 05/02/2003SE |
Questions and answers
When was Poly-Chem 90 Direct HDL Cholesterol, Poly-Chem 90 Direct LDL Cholesterol, Poly-Chem 90 Cholesterol, Poly-Chem 90 Triglyc cleared by the FDA?
Poly-Chem 90 Direct HDL Cholesterol, Poly-Chem 90 Direct LDL Cholesterol, Poly-Chem 90 Cholesterol, Poly-Chem 90 Triglyc (K100550) received a 510(k) decision of Substantially Equivalent on September 28, 2010, 214 days after the submission was received.
What is the product code of K100550?
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.