510(k) K160402 ยท CGA Glucose Oxidase, Glucose
GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)
| Applicant | Instrumentation Laboratory CO, Bedford MA, US |
| Decision | Substantially Equivalent, Dec 14, 2016 |
| Received | Feb 12, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160402
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.