FDA 510(k) Application Details - K170548

Device Classification Name	Reagent, Occult Blood   More FDA Info for this Device
510(K) Number	K170548
Device Name	Reagent, Occult Blood
Applicant	Enterix Inc. 236 Fernwood Avenue Edison, NJ 08837 US Other 510(k) Applications for this Company
Contact	Michele Houldsworth Other 510(k) Applications for this Contact
Regulation Number	864.6550   More FDA Info for this Regulation Number
Classification Product Code	KHE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/24/2017
Decision Date	10/05/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review