510(k) K925385 ยท JIX Calibrator, Multi-Analyte Mixture
REAGENTS FOR ABBOTT SPECTRUM/EPX (ELECTRO CALIBRA)
| Applicant | Alko Diagnostic Corp., Holliston MA, US |
| Decision | Substantially Equivalent, Jan 13, 1994 |
| Received | Oct 26, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K925385
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.