FDA 510(k) Application Details - K163554

Device Classification Name	Reagent, Occult Blood   More FDA Info for this Device
510(K) Number	K163554
Device Name	Reagent, Occult Blood
Applicant	Immunostics, Inc. 1750 Brielle Ave., AS Ocean, NJ 07712 US Other 510(k) Applications for this Company
Contact	Antoinette Prusik 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	12/19/2016
Decision Date	01/17/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review