FDA 510(k) Application Details - K231151

Device Classification Name	Ige, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K231151
Device Name	Ige, Antigen, Antiserum, Control
Applicant	Kenota Inc. 335 Gage Ave #1 Kitchener N2M 5E1 CA Other 510(k) Applications for this Company
Contact	Martin Mann Other 510(k) Applications for this Contact
Regulation Number	866.5510   More FDA Info for this Regulation Number
Classification Product Code	DGC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/24/2023
Decision Date	05/31/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Dual Track
Reviewed By Third Party	N
Expedited Review