FDA 510(k) Application Details - K220763

Device Classification Name	Calprotectin, Fecal   More FDA Info for this Device
510(K) Number	K220763
Device Name	Calprotectin, Fecal
Applicant	ALPCO 26-G Keewaydin Drive Salem, NH 03079 US Other 510(k) Applications for this Company
Contact	Chris Wisherd Other 510(k) Applications for this Contact
Regulation Number	866.5180   More FDA Info for this Regulation Number
Classification Product Code	NXO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/16/2022
Decision Date	04/13/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review