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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name joint biological agent identification and diagnostic system (jbaids) tularemia detection kit
510(K) Number K072547
Device Name JBAIDS TULAREMIA DETECTION KIT, MODEL JRPD-ASY-0124
Applicant
IDAHO TECHNOLOGY, INC.
390 wakara way
salt lake city,  UT  84108
Contact beth lingenfelter
Regulation Number866.3280
Classification Product Code
OEH  
Date Received09/17/2007
Decision Date 12/19/2007
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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