510(k) K963673 ยท KLT Enzyme Immunoassay, Carbamazepine
IMMAGE IMMUNOCHEMISTRY SYSTEM TDM (CAR,PHE,PHY, & THE) REAGENTS
| Applicant | Beckman Instruments, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Feb 4, 1997 |
| Received | Sep 13, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963673
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.