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FDA 510(k)

CaRi-Plaque

K-Number: K242240 · 2025-02-20

ApplicantCaristo Diagnostics , Ltd.
Decision Date2025-02-20
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CaRi-Plaque is a medical device manufactured by Caristo Diagnostics , Ltd.. It received FDA 510(k) clearance on 2025-02-20 under approval number K242240. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CaRi-Plaque?

CaRi-Plaque is a medical device that received FDA 510(k) clearance on 2025-02-20. It is manufactured by Caristo Diagnostics , Ltd.. The 510(k) number is K242240.

When was CaRi-Plaque approved by the FDA?

CaRi-Plaque received FDA 510(k) clearance on 2025-02-20, under approval number K242240.

What company makes CaRi-Plaque?

CaRi-Plaque is manufactured by Caristo Diagnostics , Ltd..

What is the FDA product code for CaRi-Plaque?

The FDA product code for CaRi-Plaque is LLZ.

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Official Source

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