510(k) K894483 ยท CFR Hexokinase, Glucose
GLUCOSE-HK TEST (GLU-HK) ITEM #65415
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Sep 7, 1989 |
| Received | Jul 18, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894483
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.