FDA 510(k) Application Details - K953606

Device Classification Name	Kit, Test, Pregnancy, Hcg, Over The Counter   More FDA Info for this Device
510(K) Number	K953606
Device Name	Kit, Test, Pregnancy, Hcg, Over The Counter
Applicant	AMERITEK, INC. 7030 35TH AVE., N.E. SEATTLE, WA 98115 US Other 510(k) Applications for this Company
Contact	H C YEE Other 510(k) Applications for this Contact
Regulation Number	862.1155   More FDA Info for this Regulation Number
Classification Product Code	LCX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/02/1995
Decision Date	03/22/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review