K244042 is an FDA 510(k) clearance for the Calcium2. This device is classified as a Azo Dye, Calcium (Class II - Special Controls, product code CJY).
Submitted by Abbott Ireland (Lisnamuck, IE). The FDA issued a Cleared decision on February 10, 2025, 42 days after receiving the submission on December 30, 2024.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1145.
| 510(k) Number | K244042 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 2024 |
| Decision Date | February 10, 2025 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CJY - Azo Dye, Calcium |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1145 |