510(k) K970921 ยท JIX Calibrator, Multi-Analyte Mixture
STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0), STANDARD C MULTIPLY (A560-0)
| Applicant | Alko Diagnostic Corp., Holliston MA, US |
| Decision | Substantially Equivalent, Apr 8, 1997 |
| Received | Mar 12, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970921
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.