510(k) K915797 ยท JIX Calibrator, Multi-Analyte Mixture
CALIBRATOR
| Applicant | Alko Diagnostic Corp., Holliston MA, US |
| Decision | Substantially Equivalent, Jan 30, 1992 |
| Received | Dec 24, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915797
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.