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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Candida Spp., Direct Antigen, Id
510(k) Number K863499
Device Name CANDIDATE(R) SUPER
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 Number866.3165
Classification Product Code
LRF  
Date Received09/09/1986
Decision Date 03/19/1987
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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