FDA 510(k) Application Details - K981892

Device Classification Name	Kit, Test, Pregnancy, Hcg, Over The Counter   More FDA Info for this Device
510(K) Number	K981892
Device Name	Kit, Test, Pregnancy, Hcg, Over The Counter
Applicant	ABACUS DIAGNOSTICS 6520 PLATT AVE., #220 WEST HILLS, CA 91307 US Other 510(k) Applications for this Company
Contact	PAMELA BAGARIA 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	05/29/1998
Decision Date	08/18/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review