510(k) K945523 ยท LCQ Fluorescent Immunoassay Gentamicin
COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORS
| Applicant | Roche Diagnostic Systems, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Mar 9, 1995 |
| Received | Nov 10, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945523
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.