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FDA 510(k) Applications Submitted by BIOFIRE DIAGNOSTICS, INC.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K130914
04/02/2013
FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL
BIOFIRE DIAGNOSTICS, INC.
K123620
11/23/2012
FILMARRAY RESPIRATORY PANEL (RP)
BIOFIRE DIAGNOSTICS, INC.
K131936
06/27/2013
JBAIDS TULAREMIA DETECTION KIT
BIOFIRE DIAGNOSTICS, INC.
K131729
06/12/2013
JBAIDS PLAGUE DETECTION KIT
BIOFIRE DIAGNOSTICS, INC.
K131930
06/27/2013
JBAIDS ANTHRAX DETECTION KIT
BIOFIRE DIAGNOSTICS, INC.
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