FDA 510(k) Applications for Medical Device Product Code: GMZ (Antigens, All Types, Escherichia Coli)

FDA 510(k) Applications for Medical Device Product Code "GMZ"
(Antigens, All Types, Escherichia Coli)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K980507	ALEXON - TREND, INC.	PROSPECT SHIGA TOXIN MICROPLATE ASSAY	04/23/1998
K972156	GUARDIAN SCIENTIFIC, CORP.	QUIX RAPID E. COLI O157 STRIP TEST	10/16/1997
K061889	INVERNESS MEDICAL-BIOSTAR INC.	BIOSTAR OIA SHIGATOX	12/12/2006
K222829	Meridian Bioscience Inc.	Curian« Shiga Toxin	04/17/2023
K023599	MERIDIAN BIOSCIENCE, INC.	IMMUNOCARD STAT! E. COLI O157 PLUS	01/03/2003
K062546	MERIDIAN BIOSCIENCE, INC.	IMMUNOCARD STAT! EHEC, MODEL 751630	02/14/2007
K990263	MERIDIAN DIAGNOSTICS, INC.	IMMUNOCARD STAT! E. COLI O157:H7	08/09/1999
K971663	MUREX BIOTECH LTD.	WELLCOLEX E.COLI O157:H7	12/30/1997
K973457	SHARED SYSTEMS, INC.	CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800	01/02/1998
K121411	TECHLAB INC., CORPORATE RESEARCH CENTER	SHIGA TOXIN CHEK	10/02/2012
K121364	TECHLAB INC., CORPORATE RESEARCH CENTER	SHIGA TOXIN QUIK CHEK	10/02/2012