K191899 is an FDA 510(k) clearance for the Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions. 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 August 16, 2019, 31 days after receiving the submission on July 16, 2019.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K191899 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 16, 2019 |
| Decision Date | August 16, 2019 |
| Days to Decision | 31 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 |