FDA 510(k) Application Details - K974021

Device Classification Name	Kit, Test, Pregnancy, Hcg, Over The Counter   More FDA Info for this Device
510(K) Number	K974021
Device Name	Kit, Test, Pregnancy, Hcg, Over The Counter
Applicant	SA SCIENTIFIC, INC. 4919 GOLDEN QUAIL SAN ANTONIO, TX 78240 US Other 510(k) Applications for this Company
Contact	HARBI SHADFAN 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	10/22/1997
Decision Date	12/19/1997
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