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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nucleic acid amplification, novel influenza a virus, a/h5 (asian lineage) rna
510(K) Number K100287
Model JRPD-ASY-0136
Device Name JBAIDS INFLUENZA A/H5 DETECTION KIT, MODEL JRPD-ASY-0136
Applicant
U.S. ARMY MEDICAL MATERIAL DEVELOPMENT COMMAND
1430 veterans drive
fort detrick,  MD 
Contact robert e miller
Regulation Number866.3332
Classification Product Code
NXD  
Date Received01/29/2010
Decision Date 07/06/2010
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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