FDA 510(k) Application Details - K962176

Device Classification Name	Prothrombin Fragment 1.2   More FDA Info for this Device
510(K) Number	K962176
Device Name	Prothrombin Fragment 1.2
Applicant	PANBIO, INC. 1539 N. IRONWOOD DR. SOUTH BEND, IN 46635 US Other 510(k) Applications for this Company
Contact	CHRISTOPHER NOTESTINE Other 510(k) Applications for this Contact
Regulation Number	864.7320   More FDA Info for this Regulation Number
Classification Product Code	MIF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/05/1996
Decision Date	10/18/1996
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