FDA 510(k) Application Details - K973954

Device Classification Name	Antisera, Cf, Influenza Virus A, B, C   More FDA Info for this Device
510(K) Number	K973954
Device Name	Antisera, Cf, Influenza Virus A, B, C
Applicant	DAKO DIAGNOSTICS LTD. DENMARK HOUSE, ANGEL DROVE, ELY CAMBRIDGESHIRE CB7 4ET GB Other 510(k) Applications for this Company
Contact	ELISABETH SILVER Other 510(k) Applications for this Contact
Regulation Number	866.3330   More FDA Info for this Regulation Number
Classification Product Code	GNW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/09/1997
Decision Date	12/22/1997
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