510(k) K855080 ยท LFR Glucose Dehydrogenase, Glucose
EMDS GLUCOSE TEST PACK ITEM 67656/95
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Feb 11, 1986 |
| Received | Dec 19, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K855080
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.