K252357 is an FDA 510(k) clearance for the Glucose2. This device is classified as a Hexokinase, Glucose (Class II - Special Controls, product code CFR).
Submitted by Abbott Ireland (Longford, IE). The FDA issued a Cleared decision on October 24, 2025, 87 days after receiving the submission on July 29, 2025.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K252357 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 2025 |
| Decision Date | October 24, 2025 |
| Days to Decision | 87 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 |