510(k) K905721 ยท LCQ Fluorescent Immunoassay Gentamicin
OPUS GENTAMICIN
| Applicant | Pb Diagnostic Systems, Inc., Westwood MA, US |
| Decision | Substantially Equivalent, Feb 21, 1991 |
| Received | Dec 21, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K905721
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.