FDA 510(k) Applications Submitted by Judi Smith

FDA 510(k) Number Submission Date Device Name Applicant
K100130 01/19/2010 PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2 MITSUBISHI CHEMICAL MEDIENCE CO
K130603 03/07/2013 PATHFAST CTNL CALIBRATORS MITSUBISHI CHEMICAL MEDIENCE CORPORATION
K130628 03/08/2013 PATHFAST CK-MB-II CALIBRATORS MITSUBISHI CHEMICAL MEDIENCE CORPORATION
K111424 05/23/2011 VACUETTE PREMIUM SAFETY NEEDLE SYSTEM TUBE-TOUCH MEDPRO SAFETY PRODUCTS, INC.
K061483 05/30/2006 VACUETTE VISIO PLUS BLOOD COLLECTION NEEDLES GREINER BIO-ONE NORTH AMERICA, INC.
K011699 06/01/2001 VACUETTE EVACUATED BLOOD COLLECTION TUBES GREINER BIO-ONE VACUETTE NORTH AMERICA
K011786 06/08/2001 VACUETTE SAFETY BLOOD COLLECTION SET GREINER VACUETTE NORTH AMERICA, INC.
K061686 06/15/2006 IDI-VANR ASSAY GENEOHM SCIENCES CANADA, INC.
K012043 06/29/2001 VACUETTE EDTA K2 GEL TUBES GREINER VACUETTE NORTH AMERICA, INC.
K081929 07/07/2008 VACUETTE BLOOD COLLECTION TUBE WITH CLOT ACTIVATOR AND GEL SEPARATOR GREINER BIO-ONE NORTH AMERICA, INC.
K101911 07/09/2010 IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION ASSAY CYLEX, INC.
K022504 07/29/2002 IDI-STREP B ASSAY INFECTIO DIAGNOSTIC, INC.
K072320 08/20/2007 GREINER VACUETTE QUICKSHIELD COMPLETE GREINER BIO-ONE NORTH AMERICA, INC.
K122687 09/04/2012 BLOOD CULTURE HOLDER GREINER BIO-ONE NORTH AMERICA, INC.
K002777 09/06/2000 VACUETTE WITH PPACK GREINER VACUETTE NORTH AMERICA, INC.
K112725 09/20/2011 LIAISON 25 OH VITAMIN D TOTAL ASSAY DIASORIN, INC.
K013169 09/21/2001 IMMUNE CELL FUNCTION ASSAY CYLEX, INC.
K102774 09/24/2010 VACUETTE QUICKSHIELD WITH SNAPPY TUDE HOLDER GREINER BIO-ONE NORTH AMERICA, INC.
K103041 10/14/2010 VACUETTE BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL SEPARATOR GREINER BIO-ONE NORTH AMERICA, INC.
K042927 10/22/2004 VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES GREINER BIO-ONE VACUETTE NORTH AMERICA
K033478 11/03/2003 VACUETTE QUICKSHIELD SAFETY TUBE HOLDER GREINER BIO-ONE VACUETTE NORTH AMERICA
K063357 11/07/2006 MINICOLLECT CAPILLARY BLOOD COLLECTION TUBES GREINER BIO-ONE NORTH AMERICA, INC.
K113505 11/28/2011 VACUETTE QUICKSHIELD WITH SNAPPY TUBE HOLDER GREINER BIO-ONE NORTH AMERICA, INC.
K023971 11/29/2002 VACUETTE TRACE ELEMENTS TUBES GREINER BIO-ONE VACUETTE NORTH AMERICA
K003812 12/11/2000 VACUETTE SPEEDY QUICK-RELEASE HOLDER GREINER VACUETTE NORTH AMERICA, INC.
K014104 12/13/2001 VACUETTE EDTA K2 TUBES GREINER VACUETTE NORTH AMERICA, INC.
K080235 01/30/2008 SAFETY INFUSION SET GREINER BIO-ONE VACUETTE NORTH AMERICA
K121908 06/29/2012 SAFETY INFUSION SET GREINER BIO-ONE NORTH AMERICA, INC.
K042357 08/31/2004 IDI-MRSA ASSAY INFECTIO DIAGNOSTIC (I.D.I.) INC.
K960420 01/29/1996 MUELLER HINTON AGAR WITH 5% SHEEP BLOOD BECTON DICKINSON MICROBIOLOGY SYSTEMS
K970931 03/07/1997 COPALIS TORC TOTAL ANTIBODY ASSAY SIENNA BIOTECH, INC.
K001118 04/07/2000 MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET DIASORIN, INC.
K991459 04/26/1999 COPALIS EBV-M ANTIBODY ASSAY DIASORIN, INC.
K961784 05/02/1996 COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYS SIENNA BIOTECH, INC.
K991660 05/14/1999 COPALIS MULTIPLEX EBV ANTIBODY ASSAY DIASORIN, INC.
K982027 06/02/1998 MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY DIASORIN, INC.
K952791 06/19/1995 DIRECTIGEN MENINGITIS COMBO TEST BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K992191 06/28/1999 ETI-EA-G ASSAY DIASORIN, INC.
K992552 07/30/1999 COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY DIASORIN, INC.
K982708 08/04/1998 SPQ TEST SYSTEM DIASORIN, INC.
K993291 10/01/1999 COPALIS RUBELLA IGM DIASORIN, INC.
K983617 10/15/1998 25-HYDROXYVITAMIN D 125I RIA KIT DIASORIN, INC.
K993669 11/01/1999 LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET DIASORIN, INC.
K983880 11/02/1998 TRANSFERRIN SPQ III ANTIBODY REAGENT SET DIASORIN, INC.
K994110 12/06/1999 LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET DIASORIN/AMERICAN STANDARD COMPANIES


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