Cholestech Lipid Monitoring System,Hdl Cholesterol
FDA 510(k) K905296 · Cholestech Corp.
510(k) numberK905296
Submission
- Device name
- Cholestech Lipid Monitoring System,Hdl Cholesterol
- Applicant
- Cholestech Corp.
Hayward, CA, US - Received
- November 27, 1990
- Decision date
- December 26, 1990
- 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 |
|---|---|---|
| K040579 | Choletech LDX High-Sensitivity C-Reactive Protein (Hs-Crp)DCK · Traditional | 06/18/2004SE |
| K032027 | Cholestech LDX Aspartate Aminotransferase (Ast)CIS · Traditional | 09/05/2003SE |
| K991834 | Cholestech LDX Alanine Aminotransferase (Alt), Model 11-772CKD · Traditional | 09/09/1999SE |
| K972012 | Cholestech Bun/Creatinine Test SystemCDN · Traditional | 07/24/1997SE |
| K954778 | Cholestech LDX SystemLBS · Traditional | 11/24/1995SE |
| K946067 | Total Cholesterol, HDL Cholesterol, Triglycerides and Glucose PanelCHH · Traditional | 02/22/1995SE |
| K946066 | Total Cholesterol, HDL Cholesterol and Glucose PanelCHH · Traditional | 02/22/1995SE |
| K946065 | Total Cholesterolm HDL Cholesterol and Triglycerides PanelCHH · Traditional | 02/22/1995SE |
| K946064 | Total Cholesterol CassetteCHH · Traditional | 02/22/1995SE |
| K946063 | Total Cholesterol and HDL Cholesterol PanelCHH · Traditional | 02/22/1995SE |
Questions and answers
When was Cholestech Lipid Monitoring System,Hdl Cholesterol cleared by the FDA?
Cholestech Lipid Monitoring System,Hdl Cholesterol (K905296) received a 510(k) decision of Substantially Equivalent on December 26, 1990, 29 days after the submission was received.
What is the product code of K905296?
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.