510(k) K883389 ยท JIW Calibrator, Surrogate
RAICHEM(TM) BILIRUBIN CONJUGATE STANDARD
| Applicant | Reagents Applications, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Dec 14, 1988 |
| Received | Aug 10, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K883389
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.