510(k) K980883 ยท CFR Hexokinase, Glucose
N-ASSAY GLU-UL
| Applicant | Crestat Diagnostics, Inc., Seattle WA, US |
| Decision | Substantially Equivalent, Sep 3, 1998 |
| Received | Mar 9, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980883
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.