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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 the device name listed in this FDA 510(k) record. The listed applicant is Kamiya Biomedical Company, LLC. It received FDA 510(k) clearance on 2025-04-18 under 510(k) 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. The listed applicant is Kamiya Biomedical Company, LLC. The 510(k) number is K242170.

When did K-ASSAY CRP (Ver.2) receive FDA 510(k) clearance?

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

Who is the listed applicant for K-ASSAY CRP (Ver.2)?

The FDA 510(k) record lists Kamiya Biomedical Company, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Kamiya Biomedical Company, LLC 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.

K192727K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)

Related Devices (Code: DCK)

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.

K201256Procise CRP, ProciseDx Analyzer, ProciseDx Calibration CartridgeProcise DiagnosticsK192028Yumizen C1200 CRPHORIBA ABX SASK192118CRP VarioSENTINEL CH. SpAK191993Yumizen C1200 CRPHORIBA ABX SASK160712VITROS Chemistry Products hsCRP ReagentOrtho Clinical DiagnosticsK142993QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go InstrumentOrion Diagnostica, OY

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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