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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Screening, Trichomonas
510(k) Number K892802
Device Name SUPER DUO
Applicant
Mercia Diagnostics , Ltd.
Mercia Houseet
Broadford Park
Guildford, Surrey England,  GB GU4 8EW
Applicant Contact DAVID H LEWIS
Correspondent
Mercia Diagnostics , Ltd.
Mercia Houseet
Broadford Park
Guildford, Surrey England,  GB GU4 8EW
Correspondent Contact DAVID H LEWIS
Regulation Number866.2660
Classification Product Code
JWZ  
Date Received04/17/1989
Decision Date 06/13/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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