FDA 510(k) Application Details - K191589

Device Classification Name	Calprotectin, Fecal   More FDA Info for this Device
510(K) Number	K191589
Device Name	Calprotectin, Fecal
Applicant	Eurospital S.p.A. Via Flavia 122 Trieste 34147 IT Other 510(k) Applications for this Company
Contact	Chiara Pelillo 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	06/14/2019
Decision Date	07/10/2019
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