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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Linked Immunoabsorbent Assay, Rotavirus
510(k) Number K873740
Device Name ROTASCREEN EIA
Applicant
Mercia Diagnostics , Ltd.
Mercia Houseet
Broadford Park
Guildford, Surrey England,  GB GU4 8EW
Applicant Contact LEWIS (PHD)
Correspondent
Mercia Diagnostics , Ltd.
Mercia Houseet
Broadford Park
Guildford, Surrey England,  GB GU4 8EW
Correspondent Contact LEWIS (PHD)
Regulation Number866.3405
Classification Product Code
LIQ  
Date Received09/15/1987
Decision Date 11/27/1987
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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