FDA 510(k) Applications Submitted by MICHELLE B BANDY

FDA 510(k) Number Submission Date Device Name Applicant
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.
K040106 01/20/2004 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -- AMPICILLIN -- GRAM POSITIVE BECTON, DICKINSON & CO.
K030677 03/04/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-VANCOMYCIN GRAM POSITIVE BECTON, DICKINSON & CO.
K031306 04/24/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN GRAM POSITIVE BECTON, DICKINSON & CO.
K021582 05/14/2002 BACTEC MGIT 960 PZA KIT BECTON, DICKINSON & CO.
K031589 05/21/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN GRAM POSITIVE BECTON, DICKINSON & CO.
K041384 05/25/2004 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME - GRAM NEGATIVE BECTON, DICKINSON & CO.
K031912 06/20/2003 BD PHOENIX AUTOMATED MICRBIOLOGY SYSTEM AMOXICILLIN/CLAVUALANTE 0.5/0.25-32/16 UG/ML BECTON, DICKINSON & CO.
K022172 07/03/2002 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM BECTON, DICKINSON & CO.
K032275 07/23/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-IMIPENEM 1-16 UG/ML GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS BECTON, DICKINSON & CO.
K032567 08/20/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFOXITIN-GRAM NEGATIVE BECTON, DICKINSON & CO.
K033362 10/21/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- CEFUROXIME GRAM NEGATIVE BECTON DICKINSON & CO.
K023634 10/29/2002 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-GENTAMICIN GN (0.25-16UG/ML) BECTON, DICKINSON & CO.
K033557 11/12/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TICARCILLIN/CLAVULANATE-GRAM NEGATIVE BECTON, DICKINSON & CO.
K023895 11/22/2002 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CIPROFLOXACIN GN BECTON, DICKINSON & CO.
K024153 12/17/2002 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TETRACYCLINE - 0.5-16 UG/ML BECTON, DICKINSON & CO.


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