FDA 510(k) Application Details - K961965

Device Classification Name	Kit, Test, Pregnancy, Hcg, Over The Counter   More FDA Info for this Device
510(K) Number	K961965
Device Name	Kit, Test, Pregnancy, Hcg, Over The Counter
Applicant	Chembio Diagnostic Systems, Inc. 55 NORTHERN BLVD. SUITE 410 GREAT NECK, NY 11021 US Other 510(k) Applications for this Company
Contact	SUSAN D GOLDSTEIN-FALK 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	05/20/1996
Decision Date	06/24/1996
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