FDA 510(k) Application Details - K002885

Device Classification Name	System, Automated Platelet Aggregation   More FDA Info for this Device
510(K) Number	K002885
Device Name	System, Automated Platelet Aggregation
Applicant	DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; BLDG. 500 MAIL BOX 514 P.O. BOX 6101, NEWARK, DE 19714-6101 US Other 510(k) Applications for this Company
Contact	RADAMES RIESGO Other 510(k) Applications for this Contact
Regulation Number	864.5700   More FDA Info for this Regulation Number
Classification Product Code	JOZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/15/2000
Decision Date	06/21/2001
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