510(k) K911940 ยท LCR Fluorescent Immunoassay, Tobramycin
OPUS(R) TOBRAMYCIN
| Applicant | Pb Diagnostic Systems, Inc., Westwood MA, US |
| Decision | Substantially Equivalent, Jul 1, 1991 |
| Received | May 1, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911940
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.