FDA 510(k) Application Details - K984269

Device Classification Name	Reagent, Occult Blood   More FDA Info for this Device
510(K) Number	K984269
Device Name	Reagent, Occult Blood
Applicant	AMERITEK, INC. 7030 35TH AVE., N.E. SEATTLE, WA 98115 US Other 510(k) Applications for this Company
Contact	K C YEE 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	10/22/1998
Decision Date	05/11/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review