510(k) K912808 ยท CFR Hexokinase, Glucose
ABBOTT QUICK START GLUCOSE (GLUE) ITEM# 5A15
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Jul 30, 1991 |
| Received | Jun 25, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912808
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.