510(k) K925101 ยท JIX Calibrator, Multi-Analyte Mixture
SYSTEMATE PLUS CALIBRATOR
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Feb 23, 1993 |
| Received | Oct 8, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K925101
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.