FDA 510(k) Application Details - K170728

Device Classification Name	Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.   More FDA Info for this Device
510(K) Number	K170728
Device Name	Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
Applicant	TECHLAB, Inc. 2001 Kraft Drive Blacksburg, VA 24060-6358 US Other 510(k) Applications for this Company
Contact	Donna T. Link Other 510(k) Applications for this Contact
Regulation Number	866.3220   More FDA Info for this Regulation Number
Classification Product Code	KHW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/09/2017
Decision Date	06/07/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review