510(k) K884382 ยท CIW Starch-Dye Bound Polymer, Amylase
AMYLASE TEST (AMYL) ITEM NUMBER: 65653
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Jan 11, 1989 |
| Received | Oct 18, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K884382
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.