FDA 510(k) Application Details - K955115

Device Classification Name	Bothrops Atrox Reagent   More FDA Info for this Device
510(K) Number	K955115
Device Name	Bothrops Atrox Reagent
Applicant	MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. 6025 NICOLLE ST. VENTURA, CA 93003 US Other 510(k) Applications for this Company
Contact	MICHAEL D BICK Other 510(k) Applications for this Contact
Regulation Number	864.8100   More FDA Info for this Regulation Number
Classification Product Code	JCO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/09/1995
Decision Date	04/03/1996
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