510(k) K092603 ยท CFR Hexokinase, Glucose
COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Dec 4, 2009 |
| Received | Aug 25, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K092603
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.