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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name yersinia spp. reagents
510(k) Number K131729
Device Name JBAIDS PLAGUE DETECTION KIT
Applicant
BIOFIRE DIAGNOSTICS, INC.
390 wakara way
salt lake city,  UT  84108
Applicant Contact cynthia phillips
Correspondent
BIOFIRE DIAGNOSTICS, INC.
390 wakara way
salt lake city,  UT  84108
Correspodent Contact cynthia phillips
Classification Product Code
OIH  
Date Received06/12/2013
Decision Date 07/31/2013
Decision substantially equivalent (SESE)
510k Review Panel Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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