Company ยท US
Cholestech Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 2004. Name variants (Inc, Corp, punctuation) are merged.
20510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 10 |
| CGA | Glucose Oxidase, Glucose | 2 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 2 |
| LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 2 |
| CDN | Urease, Photometric, Urea Nitrogen | 1 |
| CIS | Hydrazone Colorimetry, Ast/Sgot | 1 |
| CKD | Hydrazone Colorimetry, Alt/Sgpt | 1 |
| JGY | Colorimetric Method, Triglycerides | 1 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 |
| LCP | Assay, Glycosylated Hemoglobin | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 18, 2004 | K040579 | CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP) Cholestech Corp. | DCK |
| Sep 5, 2003 | K032027 | CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST) Cholestech Corp. | CIS |
| Sep 9, 1999 | K991834 | CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772 Cholestech Corp. | CKD |
| Jul 24, 1997 | K972012 | CHOLESTECH BUN/CREATININE TEST SYSTEM Cholestech Corp. | CDN |
| Nov 24, 1995 | K954778 | CHOLESTECH LDX SYSTEM Cholestech Corp. | LBS |
| Feb 22, 1995 | K946067 | TOTAL CHOLESTEROL, HDL CHOLESTEROL, TRIGLYCERIDES AND GLUCOSE PANEL Cholestech Corp. | CHH |
| Feb 22, 1995 | K946066 | TOTAL CHOLESTEROL, HDL CHOLESTEROL AND GLUCOSE PANEL Cholestech Corp. | CHH |
| Feb 22, 1995 | K946065 | TOTAL CHOLESTEROLM HDL CHOLESTEROL AND TRIGLYCERIDES PANEL Cholestech Corp. | CHH |
| Feb 22, 1995 | K946064 | TOTAL CHOLESTEROL CASSETTE Cholestech Corp. | CHH |
| Feb 22, 1995 | K946063 | TOTAL CHOLESTEROL AND HDL CHOLESTEROL PANEL Cholestech Corp. | CHH |
| Nov 9, 1993 | K932727 | CHOLESTECH L.D.X. SYSTEM Cholestech Corp. | CGA |
| Jun 24, 1992 | K922612 | CHOLESTECH LIPID MONITORING SYSTEM, TOTAL CHOLESTE Cholestech Corp. | CHH |
| Oct 30, 1991 | K914469 | CHOLESTECH LIPID MONIT SYST, TOTAL CHOL/TRIG PANEL Cholestech Corp. | CHH |
| Sep 27, 1991 | K914033 | CHOLESTECH LIPID MONITOR SYST, TRIGLYCERIDES TEST Cholestech Corp. | JGY |
| Jul 30, 1991 | K912136 | CHOLESTECH LIPID MONITORING SYS. Cholestech Corp. | CHH |
| May 15, 1991 | K911578 | CHOLESTECH L.D.X. LIPID ANALYZER, MODIFICATION Cholestech Corp. | CHH |
| Dec 26, 1990 | K905296 | CHOLESTECH LIPID MONITORING SYSTEM,HDL CHOLESTEROL Cholestech Corp. | LBS |
| Dec 26, 1990 | K904082 | CHOLESTECH LIPID MONITORING SYSTEM, GLUCOSE TEST Cholestech Corp. | CGA |
| Dec 18, 1990 | K904784 | CHOLESTECH L.D.X. LEVEL 1 CONTROL Cholestech Corp. | JJY |
| Jul 24, 1990 | K901900 | L.D.X LIPID MONITORING SYSTEM Cholestech Corp. | CHH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 23, 2008 | Cholestech Corp Cholestech GDX A1C Test Cartridge. The Cholestech GDX A1C Test is an in-vitro diagnostic test that measures hemoglobin A1c (HbA1c). Terminated |
LCP | K041635 |
| Sep 20, 2008 | Cholestech Corp Cholestech LDX High Sensitivity C-Reactive Protein (hs-CRP) Test Cassette. The Cholestech LDX high sensitivity C-Reactive Protein (hs-CRP) is an in vitro diagnostic test for the quantitative determin Terminated |
DCK | K040579 |