510(k) K913846 ยท CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt
ABBOTT QUICKSTART ALANINE AMINOTRANSFER
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Sep 19, 1991 |
| Received | Aug 28, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913846
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.