FDA 510(k) Application Details - K023599

Device Classification Name	Antigens, All Types, Escherichia Coli   More FDA Info for this Device
510(K) Number	K023599
Device Name	Antigens, All Types, Escherichia Coli
Applicant	MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DR. CINCINNATI, OH 45244 US Other 510(k) Applications for this Company
Contact	SUSAN ROLIH Other 510(k) Applications for this Contact
Regulation Number	866.3255   More FDA Info for this Regulation Number
Classification Product Code	GMZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/28/2002
Decision Date	01/03/2003
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