510(k) K043327 ยท JXM Enzyme Immunoassay, Benzodiazepine
ONLINE DAT BENZODIAZEPINES PLUS
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Feb 7, 2005 |
| Received | Dec 2, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043327
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.