K-ASSAY CRP (Ver.2)— 510(k) K242170

Name: FDA 510(k) clearance K242170
Creator: U.S. Food and Drug Administration
Published: 2025-04-18

Substantially Equivalent

Kamiya Biomedical Company, LLC

FDA 510(k) clearance K242170 for K-ASSAY CRP (Ver.2), Substantially Equivalent on 2025-04-18. Applicant: Kamiya Biomedical Company, LLC. Device class: 2.

Clearance details

Applicant: Kamiya Biomedical Company, LLC
Product code: Code DCK
Device class: Class 2
Regulation: 21 CFR 866.5270
Advisory panel: Immunology
Date received: 2024-07-24
Decision date: 2025-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tukwila, WA, US

Download summary PDF View on FDA.gov ↗

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K160712 — VITROS Chemistry Products hsCRP Reagent2017-07-14

Data sourced from openFDA. This site is unofficial and independent of the FDA.