Cholestech Corp.
Hayward, CA, US
Cholestech Corp. appears in FDA device records in Hayward, CA. FDA records list 20 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 20 510(k) clearances for Cholestech Corp. between 1990 and 2004. The busiest year on record is 1995, with 6. The most recent is 2004, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 4 |
| 1991 | 4 |
| 1992 | 1 |
| 1993 | 1 |
| 1995 | 6 |
| 1997 | 1 |
| 1999 | 1 |
| 2003 | 1 |
| 2004 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K040579 | CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP) | DCK | Substantially Equivalent | |
| K032027 | CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST) | CIS | Substantially Equivalent | |
| K991834 | CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772 | CKD | Substantially Equivalent | |
| K972012 | CHOLESTECH BUN/CREATININE TEST SYSTEM | CDN | Substantially Equivalent | |
| K954778 | CHOLESTECH LDX SYSTEM | LBS | Substantially Equivalent | |
| K946067 | TOTAL CHOLESTEROL, HDL CHOLESTEROL, TRIGLYCERIDES AND GLUCOSE PANEL | CHH | Substantially Equivalent | |
| K946066 | TOTAL CHOLESTEROL, HDL CHOLESTEROL AND GLUCOSE PANEL | CHH | Substantially Equivalent | |
| K946065 | TOTAL CHOLESTEROLM HDL CHOLESTEROL AND TRIGLYCERIDES PANEL | CHH | Substantially Equivalent | |
| K946064 | TOTAL CHOLESTEROL CASSETTE | CHH | Substantially Equivalent | |
| K946063 | TOTAL CHOLESTEROL AND HDL CHOLESTEROL PANEL | CHH | Substantially Equivalent | |
| K932727 | CHOLESTECH L.D.X. SYSTEM | CGA | Substantially Equivalent | |
| K922612 | CHOLESTECH LIPID MONITORING SYSTEM, TOTAL CHOLESTE | CHH | Substantially Equivalent | |
| K914469 | CHOLESTECH LIPID MONIT SYST, TOTAL CHOL/TRIG PANEL | CHH | Substantially Equivalent | |
| K914033 | CHOLESTECH LIPID MONITOR SYST, TRIGLYCERIDES TEST | JGY | Substantially Equivalent | |
| K912136 | CHOLESTECH LIPID MONITORING SYS. | CHH | Substantially Equivalent | |
| K911578 | CHOLESTECH L.D.X. LIPID ANALYZER, MODIFICATION | CHH | Substantially Equivalent | |
| K905296 | CHOLESTECH LIPID MONITORING SYSTEM,HDL CHOLESTEROL | LBS | Substantially Equivalent | |
| K904082 | CHOLESTECH LIPID MONITORING SYSTEM, GLUCOSE TEST | CGA | Substantially Equivalent | |
| K904784 | CHOLESTECH L.D.X. LEVEL 1 CONTROL | JJY | Substantially Equivalent | |
| K901900 | L.D.X LIPID MONITORING SYSTEM | CHH | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- JGYColorimetric Method, Triglycerides
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- CGAGlucose Oxidase, Glucose
- CKDHydrazone Colorimetry, Alt/Sgpt
- CISHydrazone Colorimetry, Ast/Sgot
- LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- CDNUrease, Photometric, Urea Nitrogen
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2457-2008 | 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 determination of C-reactive protein in whole blood or serum. Measurement of CRP is useful as an aid in the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. The test cassettes are for use with the LDX analyzer. | Test results are high, outside of control material upper limit specification. Results could be as high as 15%. | Terminated | ||
| Z-2460-2008 | Cholestech GDX A1C Test Cartridge. The Cholestech GDX A1C Test is an in-vitro diagnostic test that measures hemoglobin A1c (HbA1c). | Cholestech Corp. was notified by the foreign manufacturer of the A1C test cartridge that stability data indicated that the product would not meet performance claims through the end of its shelf life. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain