510(k) K862594 ยท JIX Calibrator, Multi-Analyte Mixture
SERACON(TM) CAL (PRODUCT NO. DO35)
| Applicant | Bhp Diagnostix, Inc., West Chester PA, US |
| Decision | Substantially Equivalent, Aug 19, 1986 |
| Received | Jul 8, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K862594
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.