FDA 510(k) Application Details - K960871

Device Classification Name	Antithrombin Iii Quantitation   More FDA Info for this Device
510(K) Number	K960871
Device Name	Antithrombin Iii Quantitation
Applicant	MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. 6025 NICOLLE ST. VENTURA, CA 93003 US Other 510(k) Applications for this Company
Contact	MICHAEL D BICK, PH.D. Other 510(k) Applications for this Contact
Regulation Number	864.7060   More FDA Info for this Regulation Number
Classification Product Code	JBQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/04/1996
Decision Date	08/14/1996
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