FDA 510(k) Application Details - K131804

Device Classification Name	Antigens, Cf (Including Cf Control), Influenza Virus A, B, C   More FDA Info for this Device
510(K) Number	K131804
Device Name	Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
Applicant	REMEL, INC. 12076 Santa Fe Trail Dr LENEXA, KS 66215 US Other 510(k) Applications for this Company
Contact	CINDY KNAPP 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	06/19/2013
Decision Date	07/12/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review