510(k) K052815 ยท KLQ Radioimmunoassay, Amikacin
QMS AMIKACIN REAGENTS
| Applicant | Seradyn, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Nov 1, 2005 |
| Received | Oct 4, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052815
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.