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FDA 510(k)

K-ASSAY CRP (Ver.2)

K-Number: K242170 · 2025-04-18

ApplicantKamiya Biomedical Company, LLC
Decision Date2025-04-18
Product CodeDCK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

K-ASSAY CRP (Ver.2) is a medical device manufactured by Kamiya Biomedical Company, LLC. It received FDA 510(k) clearance on 2025-04-18 under approval number K242170. The device is classified under product code DCK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the K-ASSAY CRP (Ver.2)?

K-ASSAY CRP (Ver.2) is a medical device that received FDA 510(k) clearance on 2025-04-18. It is manufactured by Kamiya Biomedical Company, LLC. The 510(k) number is K242170.

When was K-ASSAY CRP (Ver.2) approved by the FDA?

K-ASSAY CRP (Ver.2) received FDA 510(k) clearance on 2025-04-18, under approval number K242170.

What company makes K-ASSAY CRP (Ver.2)?

K-ASSAY CRP (Ver.2) is manufactured by Kamiya Biomedical Company, LLC.

What is the FDA product code for K-ASSAY CRP (Ver.2)?

The FDA product code for K-ASSAY CRP (Ver.2) is DCK.

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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.

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