510(k) K923677 ยท JFJ Catalytic Methods, Amylase
AMYLASE TEST
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Sep 9, 1992 |
| Received | Jul 22, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K923677
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.