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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name 2009 h1n1 influenza virus (swine origin), nucleic acid or antigen, detection and identification
510(K) Number K111778
Device Name JBAIDS INFLUENZA A SUBTYPING KIT
Applicant
U.S. ARMY MEDICAL MATERIEL DEVELOPMENT ACTIVITY
1430 veterans drive
fort detrick,  MD  21702
Contact patricia m beverly
Regulation Number866.3332
Classification Product Code
OQW  
Subsequent Product Codes
OEP   OOI  
Date Received06/23/2011
Decision Date 09/13/2011
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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