FDA 510(k) Applications Submitted by BECTON DICKINSON & CO.

FDA 510(k) Number Submission Date Device Name Applicant
K070440 02/15/2007 BD HYPOINT NEEDLE BECTON DICKINSON & CO.
K121655 06/05/2012 BD ALCOHOL SWAB BECTON DICKINSON & CO.
K050062 01/11/2005 GEMIFLOXACIN, 5UG BBL SENSI-DISC BECTON DICKINSON & CO.
K050191 01/27/2005 MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE BECTON DICKINSON & CO.
K022133 07/01/2002 BD DIRECTIGEN EZ RSV KIT BECTON DICKINSON & CO.
K012351 07/25/2001 BDPROBETEC ET CT/GC AMPLIFIED DNA ASSAY BECTON DICKINSON & CO.
K031200 04/16/2003 MODIFICATION TO BD ULTRA-FINE III PEN NEEDLE BECTON DICKINSON & CO.
K052853 10/11/2005 TIGECYCLINE 15UG BBL SENSI-DISC BECTON DICKINSON & CO.
K052876 10/12/2005 TELITHROMYCIN 15UG BBL SENSI-DISC BECTON DICKINSON & CO.
K063689 12/12/2006 BD DIRECTIGEN EZ FLU A+B TEST BECTON DICKINSON & CO.
K141474 06/03/2014 BECTON DICKINSON INTELLIPORT SYSTEM BECTON DICKINSON & CO.
K042812 10/12/2004 BBLCHROMAGAR MRSA BECTON DICKINSON & CO.
K091377 05/11/2009 BD FLU+ SYRINGE BECTON DICKINSON & CO.
K022637 08/08/2002 BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME BECTON DICKINSON & CO.
K023092 09/18/2002 BD K-4000 MICROKERATOME SYSTEM BECTON DICKINSON & CO.
K101529 06/02/2010 BD DIRECTIGEN EZ FLU A+B ASSAY BECTON DICKINSON & CO.
K101514 06/02/2010 BD DIRECTIGEN EZ RSV BECTON DICKINSON & CO.
K133140 10/17/2013 BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV BECTON DICKINSON & CO.
K133138 10/17/2013 BD VeritorÖ System Flu A+B Assay BECTON DICKINSON & CO.
K060007 01/03/2006 BD AUTOSHIELD PEN NEEDLE BECTON DICKINSON & CO.
K080998 04/07/2008 DORIPENEM 10UG BBL SENSI-DISC BECTON DICKINSON & CO.
K082272 08/11/2008 VORICONAZOLE 1UG BBL SENSI-DISC BECTON DICKINSON & CO.
K082271 08/11/2008 FLUCONAZOLE 25UG BBL SENSI-DISC BECTON DICKINSON & CO.
K041071 04/26/2004 BD VACUTAINER TRACE ELEMENT SERUM PLUS TUBE AND BD VACUTAINER TRACE ELEMENT K2EDTA PLUS TUBE, MODELS 368380/368381 BECTON DICKINSON & CO.
K022130 07/01/2002 BD VACUTAINER PLUS PST II TUBE BECTON DICKINSON & CO.
K023331 10/04/2002 BD VACUTAINER SST II PLUS TUBES BECTON DICKINSON & CO.
K140591 03/07/2014 BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - INJECTOR BECTON DICKINSON & CO.
K090680 03/16/2009 HEPARIN LOCK FLUSH SOLUTION, USP BD POSIFLUSH HEPARIN LOCK FLUSH SYRINGE BECTON DICKINSON & CO.
K121050 04/06/2012 0.9% SODIUM CHLORIDE INJECTION USP BD POSIFLUSH FLUSH SYRINGE, SF FLUSH SYRINGE BECTON DICKINSON & CO.
K123213 10/15/2012 BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE BECTON DICKINSON & CO.
K040603 03/05/2004 PARADIGM LINK BLOOD GLUCOSE METER BECTON DICKINSON & CO.
K051899 07/13/2005 BD PEN NEEDLE BECTON DICKINSON & CO.
K022581 08/05/2002 BECTON DICKINSON LOGIC BLOOD GLUCOSE MONITORING SYSTEM BECTON DICKINSON & CO.
K023219 09/26/2002 BECTON DICKINSON DIABETES SOFTWARE BECTON DICKINSON & CO.
K024112 12/13/2002 BD INSULIN SYRINGE BECTON DICKINSON & CO.
K024109 12/13/2002 BD ULTRA-FINE III PEN NEEDLE BECTON DICKINSON & CO.
K093972 12/24/2009 BD MICROTAINER MAP MICROTUBE FOR AUTOMATED PROCESS, MODEL 363706 BECTON DICKINSON & CO.
K091670 06/09/2009 BD L-CATH SINGLE AND DUAL LUMENT CATHETERS, MIDLINE CATHETER BECTON DICKINSON & CO.
K033560 11/12/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME 0.5-64 UG/ML-GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS BECTON DICKINSON & CO.
K033784 12/04/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN 0.0625-8 UG/ML BECTON DICKINSON & CO.
K102064 07/23/2010 BD FACS SAMPLE PREP ASSISTANT III (SPA III) BECTON DICKINSON & CO.
K013971 12/03/2001 BD VACUTAINER SAFETY COAGULATION TUBE BECTON DICKINSON & CO.
K131301 05/07/2013 BD FACS SAMPLE PREP ASSISTANT III BECTON DICKINSON & CO.
K051194 05/10/2005 BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER, MODELS 384647, 384667, 384687, 384648, 384668, 384688, 384649, 384669 BECTON DICKINSON & CO.
K042491 09/14/2004 BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER BECTON DICKINSON & CO.
K033500 11/05/2003 BD CAREFLOW CENTRAL VENOUS CATHETER BECTON DICKINSON & CO.
K050780 03/28/2005 BD PHOENIXTM AUTOMATED MICROBIOLOGY SYSTEM - PENICILLIN (STREP) 0.156 -32 UG/ML BECTON DICKINSON & CO.
K033350 10/20/2003 BD VACUTAINER SAFETY-LOK ADMINISTRATION SET WITH FILTER BECTON DICKINSON & CO.
K011984 06/26/2001 BD VACUTAINER PUSH BUTTON BLOOD COLECTION SET BECTON DICKINSON & CO.
K022426 07/25/2002 BD PRESET BLOOD COLLECTION SYRINGE, BD A-LINE BLOOD COLLECTION SYRINGE, MODELS 365313, 365323,365316,365356,365373,36538 BECTON DICKINSON & CO.
K022875 08/30/2002 MODIFICATION TO BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET BECTON DICKINSON & CO.
K101502 06/01/2010 BD VACUTAINER RAPID SERUM TUBE BLOOD COLLECTION TUBE, MODEL 368774 BECTON DICKINSON & CO.
K111860 06/30/2011 BD MAX GBS ASSAY, BD MAX INSTRUMENT BECTON DICKINSON & CO.
K020842 03/15/2002 ERTAPENEM 10UG BBL SENSI-DISC BECTON DICKINSON & CO.
K040006 01/02/2004 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-LINEZOLID-GRAM POSITIVE BECTON DICKINSON & CO.
K033362 10/21/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- CEFUROXIME GRAM NEGATIVE BECTON DICKINSON & CO.
K060217 01/27/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN-0.125-8 AND CIPROFLOXACIN-0.25 - 4 UG/ML BECTON DICKINSON & CO.
K060324 02/09/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM FOR USE WITH THE ANTIMICROBIAL AGENT GATIFLOXACIN 0.25-8 UG/ML - GRAM-NEGATIVE BECTON DICKINSON & CO.
K060447 02/21/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -NITROFURANTOIN (GN) 8-512 UG/ML, TRIMETHOPRIM-SULFAMETHOXAZOLE (GN) BECTON DICKINSON & CO.
K023301 10/03/2002 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM BECTON DICKINSON & CO.
K031530 05/15/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN-8-512 UG/ML BECTON DICKINSON & CO.
K100209 01/25/2010 BD ECLIPSE NEEDLE WITH SMARTSLIP TECHNOLOGY BECTON DICKINSON & CO.
K131358 05/10/2013 BD PEN NEEDLE BECTON DICKINSON & CO.
K081446 05/22/2008 BD SPINAL NEEDLE, MODELS: 405081, 405235, 405236, 405237 BECTON DICKINSON & CO.
K123300 10/23/2012 BD PEN NEEDLE BECTON DICKINSON & CO.
K043397 12/10/2004 MODIFICATION TO BD ECLIPSE HYPODERMIC NEEDLE BECTON DICKINSON & CO.
K092767 09/09/2009 BBL CHROMAGAR MRSA II BECTON DICKINSON & CO.
K123903 12/19/2012 BD BACTEC LYTIC/10 ANAEROBIC/F (PLASTIC) BECTON DICKINSON & CO.
K022580 08/05/2002 BACTON DICKINSON LATITUDE BLOOD GLUCOSE MONITORING SYSTEM BECTON DICKINSON & CO.
K032528 08/15/2003 BD ECLIPSE BIFURCATED NEEDLE BECTON DICKINSON & CO.
K042934 10/25/2004 1BD SOLOSHOT IX SYRINGE BECTON DICKINSON & CO.
K110443 02/16/2011 BD INSYTE AUTOGUARD BC BECTON DICKINSON & CO.
K091724 06/11/2009 BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY BECTON DICKINSON & CO.
K103798 12/27/2010 BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS BECTON DICKINSON & CO.
K063573 11/29/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFTAZIDIME (GN) 0.5-64 UG/ML BECTON DICKINSON & CO.


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