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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
Applicant Contact rober miller
Correspondent
U.S. ARMY MEDICAL RESEARCH INSTITUTE OF INFECTIOUS
1452 porter street
fort detrick,  MD  21702 -9232
Correspondent Contact rober miller
Regulation Number866.3870
Classification Product Code
OUZ  
Date Received07/02/2008
Decision Date 05/25/2011
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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