510(k) K955489 ยท JIX Calibrator, Multi-Analyte Mixture
CALIBRATION SERUM LEVEL 1 & 2
| Applicant | Randox Laboratories, Ltd., Crumlin, IE |
| Decision | Substantially Equivalent, Jun 21, 1996 |
| Received | Nov 27, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955489
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.