FDA 510(k) Application Details - K012386

Device Classification Name	Test, Qualitative And Quantitative Factor Deficiency   More FDA Info for this Device
510(K) Number	K012386
Device Name	Test, Qualitative And Quantitative Factor Deficiency
Applicant	AMERICAN DIAGNOSTICA, INC. 222 RAILROAD AVE. GREENWICH, CT 06830 US Other 510(k) Applications for this Company
Contact	JOHN B BERRYMAN Other 510(k) Applications for this Contact
Regulation Number	864.7290   More FDA Info for this Regulation Number
Classification Product Code	GGP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/27/2001
Decision Date	09/14/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review