510(k) K220134 ยท CFR Hexokinase, Glucose
cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Sep 16, 2022 |
| Received | Jan 18, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220134
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.