FDA 510(k) Application Details - K962028

Device Classification Name	Antisera, All Types, Escherichia Coli   More FDA Info for this Device
510(K) Number	K962028
Device Name	Antisera, All Types, Escherichia Coli
Applicant	MUREX DIAGNOSTICS, INC. 3705 NORTHWOODS CIRCLE NORCROSS, GA 30071 US Other 510(k) Applications for this Company
Contact	KEN SHOCKLEY, PH.D. 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	05/23/1996
Decision Date	11/01/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review