510(k) K010520 ยท CGA Glucose Oxidase, Glucose
GEM PREMIER 3000- ADDITION OF GLUCOSE AND LACTATE AS NEW PARAMETERS
| Applicant | Instrumentation Laboratory CO, Bedford MA, US |
| Decision | Substantially Equivalent, May 7, 2001 |
| Received | Feb 22, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010520
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.