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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
Applicant Contact PATRICIA M BEVERLY
Correspondent
U.S. ARMY MEDICAL MATERIEL DEVELOPMENT ACTIVITY
1430 VETERANS DRIVE
FORT DETRICK,  MD  21702
Correspondent 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 (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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