FDA 510(k) Application Details - K023991

Device Classification Name	Antithrombin Iii Quantitation   More FDA Info for this Device
510(K) Number	K023991
Device Name	Antithrombin Iii Quantitation
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	864.7060   More FDA Info for this Regulation Number
Classification Product Code	JBQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/03/2002
Decision Date	04/28/2003
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