510(k) K953528 ยท LEH Radioimmunoassay, Vancomycin
ROCHE COBAS-FP REAGENTS FOR VANCOMYCIN
| Applicant | Roche Diagnostic Systems, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Sep 12, 1995 |
| Received | Jul 27, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953528
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.