510(k) K920583 ยท JFJ Catalytic Methods, Amylase
ABBOTT QUICKSTART AMYLASE, #5AXX
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Mar 2, 1992 |
| Received | Feb 10, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K920583
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.