510(k) K061048 ยท CFR Hexokinase, Glucose
COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, May 17, 2006 |
| Received | Apr 17, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K061048
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.