K242170

Substantially Equivalent

K-ASSAY CRP (Ver.2)

Applicant: Kamiya Biomedical Company, LLC
Product code: DCK
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 ↗

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