FDA 510(k) Application Details - K020355

Device Classification Name	Test, Time, Prothrombin   More FDA Info for this Device
510(K) Number	K020355
Device Name	Test, Time, Prothrombin
Applicant	I-STAT CORPORATION 104 WINDSOR CENTER DR. EAST WINDSOR, NJ 08540 US Other 510(k) Applications for this Company
Contact	PAUL VANDERERF Other 510(k) Applications for this Contact
Regulation Number	864.7750   More FDA Info for this Regulation Number
Classification Product Code	GJS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/04/2002
Decision Date	05/14/2002
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