FDA 510(k)

K-ASSAY CRP (Ver.2)

N.º K: K242170 · 2025-04-18

SolicitanteKamiya Biomedical Company, LLC

Fecha de decisión2025-04-18

Código de productoDCK

Comité asesorIM

DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

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Fuente oficial

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