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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 K072631
Device Name JBAIDS PLAQUE DETECTION KIT, MODEL JRPD-ASY-0123
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 Received09/18/2007
Decision Date 12/20/2007
Decision substantially equivalent - CLIA submission (CS)
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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