510(k) K013076 ยท LEH Radioimmunoassay, Vancomycin
SYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN CALIBRATOR
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Dec 12, 2001 |
| Received | Sep 14, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013076
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 18, 2006 | Beckman Coulter Inc SYNCHRON Systems Vancomycin Reagent, in vitro diagnostic. Part Number 474824. Terminated |
LEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.