510(k) K990649 ยท CGA Glucose Oxidase, Glucose
GLUCOMETER ELITE XL BLOOD GLUCOSE METER, GLUCOMETER ELITE BLOOD GLUCOSE TEST SYSTEMS
| Applicant | Bayer Corp., Elkhart IN, US |
| Decision | Substantially Equivalent, Jul 9, 1999 |
| Received | Mar 1, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990649
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.