510(k) K113382 ยท CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt
ACE ALT REAGENT
| Applicant | Alfa Wassermann, West Caldwell NJ, US |
| Decision | Substantially Equivalent, Jul 19, 2012 |
| Received | Nov 16, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113382
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 30, 2014 | Alfa Wassermann, Inc. Alfa Wassermann Diagnostic Technologies, LLC. ACE AST Reagent.
Product Usage: For quantitative determination of AST in serum and lithium heparin plasma using ACE, ACE Alera and ACE Axcel Clinical Terminated |
CIT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.