K220134 is an FDA 510(k) clearance for the cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH. This device is classified as a Hexokinase, Glucose (Class II - Special Controls, product code CFR).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on September 16, 2022, 241 days after receiving the submission on January 18, 2022.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K220134 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 18, 2022 |
| Decision Date | September 16, 2022 |
| Days to Decision | 241 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CFR — Hexokinase, Glucose |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1345 |