FDA 510(k) Application Details - K982062

Device Classification Name	Test, Time, Partial Thromboplastin   More FDA Info for this Device
510(K) Number	K982062
Device Name	Test, Time, Partial Thromboplastin
Applicant	PRECISION BIOLOGICALS, INC. 900 WINDMILL ROAD UNIT 100 DARTMOUTH, NOVA SCOTIA B3B 1P7 CA Other 510(k) Applications for this Company
Contact	SANDY MORRISON Other 510(k) Applications for this Contact
Regulation Number	864.7925   More FDA Info for this Regulation Number
Classification Product Code	GGW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/15/1998
Decision Date	01/13/1999
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