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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 K071188
Device Name MODIFICATION TO JBAIDS ANTHRAX 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 Received04/30/2007
Decision Date 05/21/2007
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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