FDA 510(k) Application Details - K972209

Device Classification Name	Assay, Heparin   More FDA Info for this Device
510(K) Number	K972209
Device Name	Assay, Heparin
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	864.7525   More FDA Info for this Regulation Number
Classification Product Code	KFF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/11/1997
Decision Date	08/12/1997
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