FDA 510(k) Application Details - K013708

Device Classification Name	Plasma, Control, Normal   More FDA Info for this Device
510(K) Number	K013708
Device Name	Plasma, Control, Normal
Applicant	PRECISION BIOLOGIC 900 WINDMILL RD., SUITE 100 DARTMOUTH, N.S. B3B 1P7 CA Other 510(k) Applications for this Company
Contact	STEPHEN L DUFF Other 510(k) Applications for this Contact
Regulation Number	864.5425   More FDA Info for this Regulation Number
Classification Product Code	GIZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/08/2001
Decision Date	12/10/2001
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