510(k) K971405 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
SPECIALITY URINE 1,2
| Applicant | Chiron Diagnostics Corp., Irvine CA, US |
| Decision | Substantially Equivalent, Jun 16, 1997 |
| Received | Apr 16, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971405
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.