510(k) K884736 ยท CFR Hexokinase, Glucose
GLUCOSE-HK TEST (GLUC-HK) ITEM #65665
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Jan 3, 1989 |
| Received | Nov 14, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K884736
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.