510(k) K210633 ยท JFJ Catalytic Methods, Amylase
Amylase2
| Applicant | Abbott Ireland Diagnostics Division, Longsford, IE |
| Decision | Substantially Equivalent, May 26, 2022 |
| Received | Mar 3, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210633
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.