510(k) K011963 ยท CFR Hexokinase, Glucose
ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY
| Applicant | Bayer Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Nov 20, 2001 |
| Received | Jun 22, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011963
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.