510(k) K963062 ยท KXT Enzyme Immunoassay, Digoxin
IMMAGE SYSTEM DIGOXIN (DIG) REAGENT/BECKMAN DRUG CALIBRATOR 2
| Applicant | Beckman Instruments, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Dec 13, 1996 |
| Received | Aug 7, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963062
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.