FDA 510(k) Application Details - K011235

Device Classification Name	System, Multipurpose For In Vitro Coagulation Studies   More FDA Info for this Device
510(K) Number	K011235
Device Name	System, Multipurpose For In Vitro Coagulation Studies
Applicant	DADE BEHRING, INC. 13251 NW 9TH TERRACE MIAMI, FL 33182 US Other 510(k) Applications for this Company
Contact	RADAMES RIESGO Other 510(k) Applications for this Contact
Regulation Number	864.5425   More FDA Info for this Regulation Number
Classification Product Code	JPA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/23/2001
Decision Date	07/20/2001
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