510(k) K123947 ยท LEH Radioimmunoassay, Vancomycin
ARCHITECT IVANCOMYCIN
| Applicant | Biokit, S.A., Llissa D'Amunt, Barcelona, ES |
| Decision | Substantially Equivalent, Aug 29, 2013 |
| Received | Dec 21, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123947
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.