510(k) K183555 ยท JFY Enzymatic Method, Creatinine
GEM Premier ChemSTAT
| Applicant | Instrumentation Laboratory CO, Bedford MA, US |
| Decision | Substantially Equivalent, Feb 16, 2019 |
| Received | Dec 20, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183555
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.