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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 K051713
Device Name JBAIDS ANTHRAC DETECTION SYSTEM
Applicant
Idaho Technology, Inc.
390 Wakara Way
Salt Lake City,  UT  84108
Applicant Contact BETH LINGENFELTER
Correspondent
Idaho Technology, Inc.
390 Wakara Way
Salt Lake City,  UT  84108
Correspondent Contact BETH LINGENFELTER
Regulation Number866.3045
Classification Product Code
NHT  
Date Received06/27/2005
Decision Date 11/18/2005
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
Expedited Review Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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