510(k) K974125 ยท JFJ Catalytic Methods, Amylase
IL TEST AMYLASE
| Applicant | Instrumentation Laboratory CO, Lexington MA, US |
| Decision | Substantially Equivalent, Dec 17, 1997 |
| Received | Nov 3, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974125
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.