510(k) K060998 ยท LCR Fluorescent Immunoassay, Tobramycin
QMS TOBRAMYCIN
| Applicant | Seradyn, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jul 21, 2006 |
| Received | Apr 11, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060998
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.