510(k) K961337 ยท CGA Glucose Oxidase, Glucose
EXACTECH RSG BLOOD GLUCOSE TESTING SYSTEM
| Applicant | Medisense, Inc., Waltham MA, US |
| Decision | Substantially Equivalent, Jun 21, 1996 |
| Received | Apr 8, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961337
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.