510(k) K072036 ยท LEH Radioimmunoassay, Vancomycin
ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01
| Applicant | Biokit, S.A., Barcelona, ES |
| Decision | Substantially Equivalent, Mar 19, 2008 |
| Received | Jul 25, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072036
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 16, 2010 | Abbott Laboratories ARCHITECT iVancomycin Reagent; an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of vancomycin in human serum or plasma on the ARCHITECT i System with STAT Terminated |
DLJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.