510(k) K080123 ยท CFR Hexokinase, Glucose
APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201
| Applicant | Wako Chemicals USA, Inc., Richmond VA, US |
| Decision | Substantially Equivalent, Jul 17, 2008 |
| Received | Jan 17, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080123
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.