510(k) K022158 ยท CGA Glucose Oxidase, Glucose
IQM (INTELLIGENT QUALITY MANAGEMENT) ON THE GEM PREMIER 3000, CVP (CALIBRATION VALIDATION PRODUCT)
| Applicant | Instrumentation Laboratory CO, Bedford MA, US |
| Decision | Substantially Equivalent, Sep 10, 2002 |
| Received | Jul 2, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K022158
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.