510(k) K191454 ยท JFJ Catalytic Methods, Amylase
Atellica CH Amylase_2 (AMY_2)
| Applicant | Siemens Healthcare Diagnostics, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Jul 30, 2019 |
| Received | May 31, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191454
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.