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 |
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