510(k) K062239 ยท CFR Hexokinase, Glucose
GLUCOSE HK NEW FORMULATION TEST SYSTEM
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Sep 11, 2006 |
| Received | Aug 2, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K062239
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.