FDA 510(k) Application Details - K071799

Device Classification Name	Antisera, All Types, Escherichia Coli   More FDA Info for this Device
510(K) Number	K071799
Device Name	Antisera, All Types, Escherichia Coli
Applicant	IVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS 331 SOUTH 104TH ST. LOUISVILLE, CO 80027 US Other 510(k) Applications for this Company
Contact	ROBIN C HART Other 510(k) Applications for this Contact
Regulation Number	866.3255   More FDA Info for this Regulation Number
Classification Product Code	GNA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/02/2007
Decision Date	10/02/2007
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