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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nucleic amplification assays for the detection of leishmania nucleic acids
510(K) Number K081868
Device Name SMART LEISH, MODEL LGM1-050
Applicant
U.S. ARMY MEDICAL RESEARCH INSTITUTE OF INFECTIOUS
1452 porter street
fort detrick,  MD  21702 9232
Contact rober miller
Regulation Number866.3870
Classification Product Code
OUZ  
Date Received07/02/2008
Decision Date 05/25/2011
Decision substantially equivalent (SE)
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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