Cleared Traditional

K-ASSAY CRP (Ver.2)

K242170 · Kamiya Biomedical Company, LLC · Immunology

Apr 2025

Decision

268d

Days

Class 2

Risk

About This 510(k) Submission

K242170 is an FDA 510(k) clearance for the K-ASSAY CRP (Ver.2), a C-reactive Protein, Antigen, Antiserum, And Control (Class II — Special Controls, product code DCK), submitted by Kamiya Biomedical Company, LLC (Tukwila, US). The FDA issued a Cleared decision on April 18, 2025, 268 days after receiving the submission on July 24, 2024. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5270.

Submission Details

510(k) Number	K242170 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 24, 2024
Decision Date	April 18, 2025
Days to Decision	268 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF