FDA 510(k) Application Details - K232057

Device Classification Name	Calprotectin, Fecal   More FDA Info for this Device
510(K) Number	K232057
Device Name	Calprotectin, Fecal
Applicant	B▄HLMANN Laboratories AG Baselstrasse 55 Sch÷nenbuch 4124 CH Other 510(k) Applications for this Company
Contact	Laura Zurbrugg 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	07/11/2023
Decision Date	02/06/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review