510(k) K960053 ยท CGA Glucose Oxidase, Glucose
SELFCARE BLOOD GLUCOSE TEST STRIPS FOR THE EXACTECH SYSTEM
| Applicant | Selfcare, Inc., Waltham MA, US |
| Decision | Substantially Equivalent, Jun 28, 1996 |
| Received | Jan 4, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K960053
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.