FDA 510(k) Applications for Medical Device Product Code: MHI (Giardia Spp.)

FDA 510(k) Applications for Medical Device Product Code "MHI"
(Giardia Spp.)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K955157	ALEXON BIOMEDICAL, INC.	PROSPECT GIARDIA/CRYPTOSPORIDIUM MICROPLATE ASSAY	02/09/1996
K982245	BIOSITE INCORPORATED	TRIAGE,PARASITE PANEL, TRIAGE CRYPTOSPORIDIUM AND ENTAMOEBA HISTOLYTICA, TRIAGE CRYPTOSPORIDIUM AND GIARDIA LAMBLIA	10/06/1998
K983399	GENZYME DIAGNOSTICS	GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY	01/11/1999
K081064	IVD RESEARCH, INC.	GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF	01/14/2009
K024113	IVD RESEARCH, INC.	IVD CRYPTO/GIARDIA DFA	03/05/2003
K020583	IVD RESEARCH, INC.	IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96	09/17/2002
K982711	MERIDIAN DIAGNOSTICS, INC.	PREMIER GIARDIA	11/25/1998
K031942	REMEL INC	XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020	11/18/2003
K031834	REMEL INC	XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY	11/10/2003
K103673	TECHLAB INC., CORPORATE RESEARCH CENTER	GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK	08/18/2011
K955897	TECHLAB, INC.	CRYPTO/GIARDIA-CEL IF TEST	08/05/1996
K963135	TECHLAB, INC.	GIARDIA CELISA	11/29/1996
K033274	TECHLAB, INC.	GIARDIA II	11/04/2003
K120001	TRINITY BIOTECH	UNIGOLD GIARDIA	03/01/2013