FDA 510(k) Application Details - K012768

Device Classification Name	Test, Time, Prothrombin   More FDA Info for this Device
510(K) Number	K012768
Device Name	Test, Time, Prothrombin
Applicant	INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD BEDFORD, MA 01730 US Other 510(k) Applications for this Company
Contact	CAROL MARBLE 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	08/17/2001
Decision Date	09/18/2001
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