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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
Original Applicant
IDAHO TECHNOLOGY, INC.
390 wakara way
salt lake city,  UT  84108
Original Contact beth lingenfelter
Regulation Number866.2660
Classification Product Code
NHT  
Date Received06/27/2005
Decision Date 11/18/2005
Decision substantially equivalent (SE)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review Yes
Combination Product No
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