510(k) K953847 ยท CFR Hexokinase, Glucose
ROCHE REAGENT FOR GLUCOSE
| Applicant | Roche Diagnostic Systems, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, Feb 13, 1996 |
| Received | Aug 16, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953847
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.