510(k) K930678 ยท JFJ Catalytic Methods, Amylase
AMYLASE
| Applicant | Horizon Diagnostics, Inc., Ann Arbor MI, US |
| Decision | Substantially Equivalent, Apr 6, 1994 |
| Received | Feb 9, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K930678
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.