HDL-Cholesterol Gen.4
FDA 510(k) K162593 · Roche Diagnostics Operations (Rdo)
510(k) numberK162593
Submission
- Device name
- HDL-Cholesterol Gen.4
- Applicant
- Roche Diagnostics Operations (Rdo)
Indianapolis, IN, US - Received
- September 16, 2016
- Decision date
- October 19, 2016
- 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 |
|---|---|---|---|
| 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 |
| K073497 | HDL Cholesterol Reagent, Model 10211LBS · Traditional | Medica Corp. | 04/14/2008SE |
More from Medica Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K193053 | Tina-quant Hemoglobin A1cDx Gen.3PDJ · Traditional | 03/26/2020SE |
| K192072 | Tina-quant C-Reactive Protein IVDCN · Traditional | 02/21/2020SE |
| K183517 | Ammonia IIJIF · Traditional | 02/08/2019SE |
| K182095 | Tina-quant Transferrin ver.2 (urine application)DDG · Traditional | 11/05/2018SE |
| K171080 | ALP IFCC Gen.2CJE · Special | 05/10/2017SE |
| K160571 | cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 AssayPDJ · Traditional | 12/19/2016SE |
| K161817 | Tina-quant Cystatin C Gen.2NDY · Special | 07/27/2016SE |
| K160570 | Creatine KinaseJHS · Traditional | 05/25/2016SE |
| K152245 | ONLINE TDM Vancomycin Gen.3LEH · Traditional | 01/08/2016SE |
| K151578 | Carbamazepine Gen 4KLT · Traditional | 10/22/2015SE |
Questions and answers
When was HDL-Cholesterol Gen.4 cleared by the FDA?
HDL-Cholesterol Gen.4 (K162593) received a 510(k) decision of Substantially Equivalent on October 19, 2016, 33 days after the submission was received.
What is the product code of K162593?
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.