510(k) K050419 ยท LEH Radioimmunoassay, Vancomycin
QMS VANCOMYCIN
| Applicant | Seradyn, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Apr 1, 2005 |
| Received | Feb 18, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050419
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 29, 2008 | Seradyn, Inc. Seradyn QMS Vancomycin reagents, Part Number: 0373589. Seradyn, Inc, Indianapolis, IN. Terminated |
LEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.