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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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