510(k) K032027 ยท CIS Hydrazone Colorimetry, Ast/Sgot
CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST)
| Applicant | Cholestech Corp., Hayward CA, US |
| Decision | Substantially Equivalent, Sep 5, 2003 |
| Received | Jul 1, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032027
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 17, 2013 | Alere San Diego, Inc. Alere Cholestech LDX ALT AST Test Cassette, Model #12-788.
For the in vitro quantitative determination of alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Terminated |
CKD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.