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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 K152523
Device Name JBAIDS Influenza A & B Detection Kit
Applicant
U.S. ARMY MEDICAL MATERIEL DEVELOPMENT ACTIVITY
1430 VETERANS DRIVE
FORT DETRICK,  MD  21702 -9232
Applicant Contact ROBERT E MILLER
Correspondent
U.S. ARMY MEDICAL MATERIEL DEVELOPMENT ACTIVITY
1430 VETERANS DRIVE
FORT DETRICK,  MD  21702 -9232
Correspondent Contact ROBERT E MILLER
Regulation Number866.3980
Classification Product Code
OCC  
Date Received09/03/2015
Decision Date 10/01/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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