510(k) K191899 ยท CFR Hexokinase, Glucose
Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Aug 16, 2019 |
| Received | Jul 16, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191899
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 27, 2026 | Roche Diagnostics Operations, Inc. cobas pro integrated solutions with cobas c 503 analytical units:
cobas pro sample supply unit, material number 08464502001
cobas pro SSU, material number 09205632001
Affected Assays:
(Product Name Open, Classified |
JJE | None listed |
| Dec 8, 2020 | Roche Diagnostics Operations, Inc. Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e 801 analytical units) Chemistry Analyzer (photometric discrete), for clinical use
Part Number: 05641446001 Open, Classified |
JJE | None listed |
| Nov 23, 2020 | Roche Diagnostics Operations, Inc. cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use Terminated |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.