510(k) K912519 ยท JFJ Catalytic Methods, Amylase
AMYLASE REAGENT
| Applicant | Genzyme Corp., Cambridge MA, US |
| Decision | Substantially Equivalent, Jul 1, 1991 |
| Received | Jun 6, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912519
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.