Cleared Traditional

Calcium2

K244042 · Abbott Ireland · Chemistry

Feb 2025

Decision

42d

Days

Class 2

Risk

About This 510(k) Submission

K244042 is an FDA 510(k) clearance for the Calcium2, 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 review panel. Regulated under 21 CFR 862.1145.

Submission Details

510(k) Number	K244042 FDA.gov
FDA Decision	Cleared 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