510(k) K011843 ยท JFJ Catalytic Methods, Amylase
GENZYME DIRECT-AMYLASE TEST REAGENT
| Applicant | Genzyme Corp., Cambridge MA, US |
| Decision | Substantially Equivalent, Aug 10, 2001 |
| Received | Jun 12, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011843
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.