510(k) K000556 ยท CFR Hexokinase, Glucose
ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS
| Applicant | Elan Diagnostics, Brea CA, US |
| Decision | Substantially Equivalent, May 17, 2000 |
| Received | Feb 18, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000556
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.