510(k) K964670 ยท LFW Fluorescence Polarization Immunoassay, Tobramycin
ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN
| Applicant | Roche Diagnostic Systems, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Feb 4, 1997 |
| Received | Nov 21, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964670
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.