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.
K920230 01/17/1992 AFFINITY PRG BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
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.
K914022 09/09/1991 SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUS PHARMACIA DIAGNOSTICS, INC.
K920078 01/08/1992 AFFINITY B12 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K950123 01/12/1995 SCEPTOR SYSTEM PANELS BECTON DICKINSON MICROBIOLOGY SYSTEMS
K930640 01/28/1993 PRECISE PREGNANCY BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K960420 01/29/1996 MUELLER HINTON AGAR WITH 5% SHEEP BLOOD BECTON DICKINSON MICROBIOLOGY SYSTEMS
K921012 03/03/1992 PRECISE CHROMATOGRAPHIC IMMUNOASSAY FOR HCG BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K970931 03/07/1997 COPALIS TORC TOTAL ANTIBODY ASSAY SIENNA BIOTECH, INC.
K931294 03/15/1993 IQ TUPTAKE ASSAY BECTON DICKINSON ADVANCED DIAGNOSTICS
K931295 03/15/1993 IQ TT4 ASSAY BECTON DICKINSON ADVANCED DIAGNOSTICS
K951539 04/03/1995 ENTEROCOCCUS SCREENING MEDIUM BECTON DICKINSON MICROBIOLOGY SYSTEMS
K951542 04/03/1995 DIRECTIGEN 1-2-3 GROUP A STREP TEST BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
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.
K912026 05/07/1991 DELFIA(R) 17 -OH-PROGESTERON KIT PHARMACIA DIAGNOSTICS, 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
K923060 06/25/1992 IQ IMMUNOCHEMISTRY SISTEM; IQ TSH ASSAY BECTON DICKINSON ADVANCED DIAGNOSTICS
K992191 06/28/1999 ETI-EA-G ASSAY DIASORIN, INC.
K943407 07/14/1994 GENTAMICIN 120 UG, STREPTOMYCIN 30 UG SENSI-DISC SUSPECTIBILITY TESTS BECTON DICKINSON MICROBIOLOGY SYSTEMS
K923673 07/22/1992 PRECISE STREP A BECTON DICKINSON ADVANCED DIAGNOSTICS
K992552 07/30/1999 COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY DIASORIN, INC.
K982708 08/04/1998 SPQ TEST SYSTEM DIASORIN, INC.
K944528 09/15/1994 BBLCRYSTAL ANAEROBE ID SYSTEM BECTON DICKINSON MICROBIOLOGY SYSTEMS
K993291 10/01/1999 COPALIS RUBELLA IGM DIASORIN, INC.
K945569 10/11/1994 GCII AGAR WITH ISOVITALX(R) ENRICHMENT BECTON DICKINSON MICROBIOLOGY SYSTEMS
K925132 10/13/1992 BECTON DICKINSON THYROID STIMULATING HORMONE SYSTE BECTON DICKINSON ADVANCED DIAGNOSTICS
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.
K925842 11/18/1992 BECTON DICKINSON SIMULTRAC COMPONENT SYSTEM BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K915197 11/19/1991 PRECISE TM HCG BECTON DICKINSON ADVANCED DIAGNOSTICS
K915200 11/19/1991 PRECISE TM HCG FOR USE IN THE PHYSICIANS OFFICE LA BECTON DICKINSON ADVANCED DIAGNOSTICS
K935667 11/26/1993 QTEST(R) STREP BECTON DICKINSON ADVANCED DIAGNOSTICS
K994110 12/06/1999 LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET DIASORIN/AMERICAN STANDARD COMPANIES
K926356 12/21/1992 PRECISE(TM) HCG(URINE/SERUM) AND PRCISE(TM) PREG BECTON DICKINSON ADVANCED DIAGNOSTICS


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