FDA 510(k)

Calcium2

K-Number: K244042 · 2025-02-10

Decision Date2025-02-10

Product CodeCJY

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

Calcium2 is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Ireland. It received FDA 510(k) clearance on 2025-02-10 under 510(k) 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. The listed applicant is Abbott Ireland. The 510(k) number is K244042.

When did Calcium2 receive FDA 510(k) clearance?

Calcium2 received FDA 510(k) clearance on 2025-02-10, under 510(k) number K244042.

Who is the listed applicant for Calcium2?

The FDA 510(k) record lists Abbott Ireland as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Calcium2?

The FDA product code for Calcium2 is CJY.

Other records listing Abbott Ireland as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252357Glucose2

Related Devices (Code: CJY)

K191396Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine JaffeHORIBA ABX SAS K182042Randox Calcium (Ca)Randox Laboratories, Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.