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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name assay, direct, nucleic acid amplification, q fever
510(k) Number K103207
Model JRPD-ASY-0016
Device Name JBAIDS Q FEVER DETECTION KIT
Original Applicant
IDAHO TECHNOLOGY, INC.
390 wakara way
salt lake city,  UT  84108
Original Contact beth lingenfelter
Regulation Number866.3500
Classification Product Code
OVF  
Date Received11/01/2010
Decision Date 05/20/2011
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 No
Combination Product No
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