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FDA 510(k)

Cholesterol2

K-Number: K203597 · 2022-06-30

Decision Date2022-06-30
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Cholesterol2 is a medical device manufactured by Abbott Ireland Diagnostics Division. It received FDA 510(k) clearance on 2022-06-30 under approval number K203597. The device is classified under product code CHH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cholesterol2?

Cholesterol2 is a medical device that received FDA 510(k) clearance on 2022-06-30. It is manufactured by Abbott Ireland Diagnostics Division. The 510(k) number is K203597.

When was Cholesterol2 approved by the FDA?

Cholesterol2 received FDA 510(k) clearance on 2022-06-30, under approval number K203597.

What company makes Cholesterol2?

Cholesterol2 is manufactured by Abbott Ireland Diagnostics Division.

What is the FDA product code for Cholesterol2?

The FDA product code for Cholesterol2 is CHH.

Other Devices by Abbott Ireland Diagnostics Division

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Related Devices (Code: CHH)

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.