FDA 510(k) Applications for Medical Device Product Code "LLH"
(Reagents, Clostridium Difficile Toxin)
FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K964864 |
ALEXON BIOMEDICAL, INC. |
PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAY |
02/04/1997 |
K980185 |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
COLORPAC TOXIN A |
07/17/1998 |
K081920 |
BD DIAGNOSTICS (GENEOHM SCIENCES, INC.) |
BD GENEOHM CDIFF ASSAY |
12/19/2008 |
K964887 |
BIOMERIEUX VITEK, INC. |
VIDAS C. DIFFICILE TOXIN A II ASSAY |
04/08/1997 |
K072138 |
BIOMERIEUX, INC. |
VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118 |
12/21/2007 |
K080931 |
BIOMERIEUX, INC. |
VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY |
06/11/2008 |
K991829 |
BIOSTAR, INC. |
CDTOX A OIA |
11/02/1999 |
K091109 |
CEPHEID |
XPERT C. DIFFICILE |
07/09/2009 |
K193490 |
First Light Diagnostics, Inc. |
SensiTox C. difficile Toxin Test |
07/08/2021 |
K102242 |
GENZYME CORPORATION |
OSOM C. DIFFICILE TOXIN A/B TEST |
12/21/2010 |
K990664 |
INTRACEL CORP. |
PRIMA SYSTEM - OLD, BARTELS ELISA - NEW |
03/31/1999 |
K032897 |
IVD RESEARCH, INC. |
C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL; CDIFF-96 |
05/27/2004 |
K041003 |
MERIDIAN BIOSCIENCE, INC. |
IMMUNOCARD TOXINS A & B, MODEL 712050 |
08/20/2004 |
K955859 |
MERIDIAN DIAGNOSTICS, INC. |
IMMUNOCARD TOXIN A |
04/18/1996 |
K993914 |
MERIDIAN DIAGNOSTICS, INC. |
PREMIER TOXINS A&B, MODEL 616096 |
12/10/1999 |
K090239 |
PRODESSE, INC. |
PROGASTRO CD ASSAY |
04/16/2009 |
K033479 |
REMEL INC |
PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY |
02/26/2004 |
K041951 |
REMEL INC |
XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B |
11/15/2004 |
K030991 |
TECHLAB, INC. |
C. DIFF CHEK - 30 |
07/11/2003 |
K030992 |
TECHLAB, INC. |
C. DIFF CHEK - 60 |
07/11/2003 |
K082499 |
TECHLAB, INC. |
C. DIFF QUIK CHEK COMPLETE |
03/26/2009 |
K030404 |
TECHLAB, INC. |
C. DIFFICILE TOX A/B II |
04/24/2003 |
K003306 |
TECHLAB, INC. |
C. DIFFICILE TOX A/B II |
11/22/2000 |
K050891 |
TECHLAB, INC. |
TOX A/B QUICK CHEK |
07/25/2005 |
K971182 |
TECHLAB, INC. |
TOX A/B TEST |
07/22/1997 |
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