FDA 510(k)

CaRi-Plaque

K-Number: K242240 · 2025-02-20

Decision Date2025-02-20

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CaRi-Plaque is the device name listed in this FDA 510(k) record. The listed applicant is Caristo Diagnostics , Ltd.. It received FDA 510(k) clearance on 2025-02-20 under 510(k) 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. The listed applicant is Caristo Diagnostics , Ltd.. The 510(k) number is K242240.

When did CaRi-Plaque receive FDA 510(k) clearance?

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

Who is the listed applicant for CaRi-Plaque?

The FDA 510(k) record lists Caristo Diagnostics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CaRi-Plaque?

The FDA product code for CaRi-Plaque is LLZ.

Other records listing Caristo Diagnostics , Ltd. 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.

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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.