FDA 510(k) Application Details - K970607

Device Classification Name	Plasma, Coagulation Factor Deficient   More FDA Info for this Device
510(K) Number	K970607
Device Name	Plasma, Coagulation Factor Deficient
Applicant	UNIVERSAL REAGENTS, INC. 2858 N. PENNSYLVANIA ST. INDIANAPOLIS, IN 46205 US Other 510(k) Applications for this Company
Contact	JORGE MILLER Other 510(k) Applications for this Contact
Regulation Number	864.7290   More FDA Info for this Regulation Number
Classification Product Code	GJT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/18/1997
Decision Date	04/25/1997
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