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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