510(k) K131515 ยท KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT
| Applicant | Alfa Wassermann, West Caldwell NJ, US |
| Decision | Substantially Equivalent, Aug 14, 2013 |
| Received | May 28, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131515
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.