510(k) K051307 ยท JXM Enzyme Immunoassay, Benzodiazepine
SYNCHRON SYSTEMS BEBZODIAZAPINE (EBNZ) REAGENT
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Jun 13, 2005 |
| Received | May 19, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K051307
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.