510(k) K131351 ยท CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT
| Applicant | Alfa Wassermann Diagnostic Technologies, LLC, West Caldwell NJ, US |
| Decision | Substantially Equivalent, Aug 15, 2013 |
| Received | May 10, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131351
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 30, 2014 | Alfa Wassermann, Inc. Alfa Wassermann Diagnostic Technologies, LLC. ACE ALT Reagent.
Product Usage: For quantitative determination of ALT in serum and lithium heparin plasma using ACE, ACE Alera and ACE Axcel Clinical Terminated |
CKA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.