510(k) K253490 ยท CFR Hexokinase, Glucose
Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Feb 12, 2026 |
| Received | Oct 24, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253490
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.