510(k) K991834 ยท CKD Hydrazone Colorimetry, Alt/Sgpt
CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772
| Applicant | Cholestech Corp., Hayward CA, US |
| Decision | Substantially Equivalent, Sep 9, 1999 |
| Received | May 28, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991834
| 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.