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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name respiratory virus panel nucleic acid assay system
510(k) Number K111775
Device Name JBAIDS INFLUENZA A&B DETECTION KIT
Applicant
U.S. ARMY MEDICAL MATERIAL DEVELOPMENT ACITVITY
1430 VETERANS DRIVE
fort detrick,  MD  21702
Applicant Contact patricia beverly
Correspondent
U.S. ARMY MEDICAL MATERIAL DEVELOPMENT ACITVITY
1430 VETERANS DRIVE
fort detrick,  MD  21702
Correspondent Contact patricia beverly
Regulation Number866.3980
Classification Product Code
OCC  
Subsequent Product Code
OOI  
Date Received06/23/2011
Decision Date 09/13/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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