510(k) K023048 ยท JXM Enzyme Immunoassay, Benzodiazepine
MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Nov 7, 2002 |
| Received | Sep 13, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K023048
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.