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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Nucleic Acid Amplification, Bacillus Anthracis
510(k) Number K131930
Device Name JBAIDS ANTHRAX 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
Correspondent Contact CYNTHIA PHILLIPS
Regulation Number866.3045
Classification Product Code
NHT  
Date Received06/27/2013
Decision Date 08/05/2013
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
Recalls CDRH Recalls
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