FDA 510(k) Application Details - K180971

Device Classification Name	Calprotectin, Fecal   More FDA Info for this Device
510(K) Number	K180971
Device Name	Calprotectin, Fecal
Applicant	Inova Diagnostics, Inc. 9900 Old Grove Road San Diego, CA 92131-1638 US Other 510(k) Applications for this Company
Contact	Roger Albesa 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	04/13/2018
Decision Date	10/16/2018
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