510(k) K904082 ยท CGA Glucose Oxidase, Glucose
CHOLESTECH LIPID MONITORING SYSTEM, GLUCOSE TEST
| Applicant | Cholestech Corp., Hayward CA, US |
| Decision | Substantially Equivalent, Dec 26, 1990 |
| Received | Sep 5, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K904082
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 1, 2011 | Biosite Inc Dba Innovacon Inc. Cholestech LDX Lipid Profile"GLU test cassettes, Catalog Number 10-991, Lot # 245104
Cholestech LDX Lipid-Glucose tests are intended for the quantitative determination of total cholesterol, HDL (high Terminated |
CGA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.