Cholestech Corp.
Medical device manufacturer in Hayward, CA.
20510(k) clearances
0PMA approvals
2recalls
Device types
- CHH Enzymatic Esterase--Oxidase, Cholesterol 10
- CGA Glucose Oxidase, Glucose 2
- LBS Ldl & Vldl Precipitation, Cholesterol Via… 2
- JJY Multi-Analyte Controls, All Kinds (Assayed) 1
- JGY Colorimetric Method, Triglycerides 1
- CDN Urease, Photometric, Urea Nitrogen 1
- CKD Hydrazone Colorimetry, Alt/Sgpt 1
- CIS Hydrazone Colorimetry, Ast/Sgot 1
- DCK C-Reactive Protein, Antigen, Antiserum, And… 1
510(k) clearances
| 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 |
| K932727 | Cholestech L.D.X. SystemCGA · Traditional | 11/09/1993SE |
| K922612 | Cholestech Lipid Monitoring System, Total CholesteCHH · Traditional | 06/24/1992SE |
| K914469 | Cholestech Lipid Monit Syst, Total Chol/Trig PanelCHH · Traditional | 10/30/1991SE |
| K914033 | Cholestech Lipid Monitor Syst, Triglycerides TestJGY · Traditional | 09/27/1991SE |
| K912136 | Cholestech Lipid Monitoring Sys.CHH · Traditional | 07/30/1991SE |
| K911578 | Cholestech L.D.X. Lipid Analyzer, ModificationCHH · Traditional | 05/15/1991SE |
| K905296 | Cholestech Lipid Monitoring System,Hdl CholesterolLBS · Traditional | 12/26/1990SE |
| K904082 | Cholestech Lipid Monitoring System, Glucose TestCGA · Traditional | 12/26/1990SE |
| K904784 | Cholestech L.D.X. Level 1 ControlJJY · Traditional | 12/18/1990SE |
| K901900 | L.D.X Lipid Monitoring SystemCHH · Traditional | 07/24/1990SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2457-2008 | Cholestech LDX High Sensitivity C-Reactive Protein (hs-CRP) Test Cassette. The…Test results are high, outside of control material upper limit specification. Results could be as high as 15%. | 08/09/2006Terminated |
| Z-2460-2008 | Cholestech GDX A1C Test Cartridge. The Cholestech GDX A1C Test is an in-vitro diagnostic…Cholestech Corp. was notified by the foreign manufacturer of the A1C test cartridge that stability data… | 08/03/2006Terminated |