K252104 is an FDA 510(k) clearance for the T1D1. This device is classified as a Calculator, Drug Dose (Class II - Special Controls, product code NDC).
Submitted by Comerge AG (Zurich, CH). The FDA issued a Cleared decision on August 20, 2025, 48 days after receiving the submission on July 3, 2025.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 868.1890.
| 510(k) Number | K252104 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 03, 2025 |
| Decision Date | August 20, 2025 |
| Days to Decision | 48 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | NDC - Calculator, Drug Dose |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1890 |