FDA 510(k) Application Details - K971494

Device Classification Name	Antigens, Cf (Including Cf Control), Influenza Virus A, B, C   More FDA Info for this Device
510(K) Number	K971494
Device Name	Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
Applicant	ZYMETX, INC. 800 RESEARCH PKWY. SUITE 100 OKLAHOMA CITY, OK 73104 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	GNX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/24/1997
Decision Date	09/10/1997
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