510(k) K182474 ยท JFJ Catalytic Methods, Amylase
alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL
| Applicant | Biosystems S.A., Barcelona, ES |
| Decision | Substantially Equivalent, May 2, 2019 |
| Received | Sep 10, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182474
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.