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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 immunoabsorption assay, treponema pallidum
510(k) Number K871548
Device Name CAPTIA(R) SYPHILIS-M
Applicant
MERCIA DIAGNOSTICS LTD.
MERCIA HOUSEET
BROADFORD PARK
GUILDFORD, SURREY ENGLAND,  GB GU4 8EW
Applicant Contact LEWIS, PH.D.
Correspondent
MERCIA DIAGNOSTICS LTD.
MERCIA HOUSEET
BROADFORD PARK
GUILDFORD, SURREY ENGLAND,  GB GU4 8EW
Correspondent Contact LEWIS, PH.D.
Regulation Number866.3830
Classification Product Code
LIP  
Date Received04/20/1987
Decision Date 08/07/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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