510(k) K801297 ยท CFR Hexokinase, Glucose
COBAS REAGENT FOR GLUCOSE RAPID
| Applicant | Roche Analytical Instruments, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jun 30, 1980 |
| Received | Jun 2, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K801297
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.