510(k) K961311 ยท LFR Glucose Dehydrogenase, Glucose
HEMOCUE B-GLUCOSE SYSTEM
| Applicant | Hemocue, Inc., Potomac MD, US |
| Decision | Substantially Equivalent, Aug 23, 1996 |
| Received | Apr 4, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961311
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.