Calcium2
K-Number: K244042 · 2025-02-10
ApplicantAbbott Ireland
Decision Date2025-02-10
Product CodeCJY
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
Calcium2 is a medical device manufactured by Abbott Ireland. It received FDA 510(k) clearance on 2025-02-10 under approval number K244042. The device is classified under product code CJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Calcium2?
Calcium2 is a medical device that received FDA 510(k) clearance on 2025-02-10. It is manufactured by Abbott Ireland. The 510(k) number is K244042.
When was Calcium2 approved by the FDA?
Calcium2 received FDA 510(k) clearance on 2025-02-10, under approval number K244042.
What company makes Calcium2?
Calcium2 is manufactured by Abbott Ireland.
What is the FDA product code for Calcium2?
The FDA product code for Calcium2 is CJY.
Other Devices by Abbott Ireland
Related Devices (Code: CJY)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.