FDA 510(k) Applications Submitted by JANINE MATLAK

FDA 510(k) Number Submission Date Device Name Applicant
K080998 04/07/2008 DORIPENEM 10UG BBL SENSI-DISC BECTON DICKINSON & CO.
K061355 05/15/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMPICILLIN (GN) 0.5-32 UG/ML BECTON, DICKINSON & CO.
K061867 07/03/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFAZOLIN (GN) 0.5-32 UG/ML BECTON, DICKINSON & CO.
K062206 08/01/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN (STREP) 0.0625 - 8UG/ML BECTON, DICKINSON & CO.
K082271 08/11/2008 FLUCONAZOLE 25UG BBL SENSI-DISC BECTON DICKINSON & CO.
K082272 08/11/2008 VORICONAZOLE 1UG BBL SENSI-DISC BECTON DICKINSON & CO.
K062687 09/08/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEN - TICARCILLIN-CLAVULANATE (GN) 1/2 - 128/2UG/ML BECTON, DICKINSON & CO.
K062944 09/28/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTRIAXONE (GN) 0.5-64UG/ML BECTON, DICKINSON & CO.
K082852 09/29/2008 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN (GP) 4-128 UG/ML BECTON, DICKINSON & CO.
K063301 11/01/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFEPIME (GN) 0.5-64UG/ML BECTON, DICKINSON & CO.
K063811 12/22/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFAZOLIN (GN) 0.5-32UG/ML BECTON, DICKINSON & CO.
K063824 12/26/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AZTREONAM (GN) 0.5-64UG/ML BECTON, DICKINSON & CO.


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