Biofire Diagnostics, Inc. - FDA 510(k) Cleared Devices
Recent clearances: JBAIDS ANTHRAX DETECTION KIT, JBAIDS PLAGUE DETECTION KIT, JBAIDS TULAREMIA DETECTION KIT
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Biofire Diagnostics, Inc. Microbiology ✕
5 devices
Cleared
Aug 05, 2013
JBAIDS ANTHRAX DETECTION KIT
Microbiology
39d
Cleared
Jul 31, 2013
JBAIDS PLAGUE DETECTION KIT
Microbiology
49d
Cleared
Jul 31, 2013
JBAIDS TULAREMIA DETECTION KIT
Microbiology
34d
Cleared
Jun 21, 2013
FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL
Microbiology
80d
Cleared
Feb 11, 2013
FILMARRAY RESPIRATORY PANEL (RP)
Microbiology
80d