FDA 510(k) Application Details - K023582

Device Classification Name	Activated Whole Blood Clotting Time   More FDA Info for this Device
510(K) Number	K023582
Device Name	Activated Whole Blood Clotting Time
Applicant	I-STAT CORPORATION 104 WINDSOR CENTER DR. EAST WINDSOR, NJ 08520 US Other 510(k) Applications for this Company
Contact	PAUL VANDERWERF Other 510(k) Applications for this Contact
Regulation Number	864.7140   More FDA Info for this Regulation Number
Classification Product Code	JBP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/24/2002
Decision Date	09/08/2003
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