FDA 510(k) Application Details - K242170

Device Classification Name	C-Reactive Protein, Antigen, Antiserum, And Control   More FDA Info for this Device
510(K) Number	K242170
Device Name	C-Reactive Protein, Antigen, Antiserum, And Control
Applicant	Kamiya Biomedical Company, LLC 12779 Gateway Dr S Tukwila, WA 98168 US Other 510(k) Applications for this Company
Contact	Shawn Kaplan Other 510(k) Applications for this Contact
Regulation Number	866.5270   More FDA Info for this Regulation Number
Classification Product Code	DCK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/24/2024
Decision Date	04/18/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review