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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name joint biological agent identification and diagnostic system (jbaids) tularemia detection kit
510(k) Number K131936
Device Name JBAIDS TULAREMIA DETECTION KIT
Applicant
BIOFIRE DIAGNOSTICS, INC.
390 wakara way
salt lake city,  UT  84108
Applicant Contact cynthia philips
Correspondent
BIOFIRE DIAGNOSTICS, INC.
390 wakara way
salt lake city,  UT  84108
Correspodent Contact cynthia philips
Regulation Number866.3280
Classification Product Code
OEH  
Date Received06/27/2013
Decision Date 07/31/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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