FDA 510(k) Application Details - K950838

Device Classification Name	Antigens, Ha (Including Ha Control), Influenza Virus A, B, C   More FDA Info for this Device
510(K) Number	K950838
Device Name	Antigens, Ha (Including Ha Control), Influenza Virus A, B, C
Applicant	ZYMETX, INC. 25 NORTHWEST 4TH ST. OKLAHOMA CITY, OK 73102 US Other 510(k) Applications for this Company
Contact	CRAIG D SHIMASAKI Other 510(k) Applications for this Contact
Regulation Number	866.3330   More FDA Info for this Regulation Number
Classification Product Code	GNT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/24/1995
Decision Date	06/17/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review