510(k) K864464 ยท JFJ Catalytic Methods, Amylase
PSI AMYLASE REAGENT
| Applicant | Pointe Scientific, Inc.,, Detroit MI, US |
| Decision | Substantially Equivalent, Jan 21, 1987 |
| Received | Nov 12, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864464
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.