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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 K881425
Device Name CAPTIA(R) SYPHILIS-G
Applicant
MERCIA DIAGNOSTICS LTD.
MERCIA HOUSEET
BROADFORD PARK
GUILDFORD, SURREY ENGLAND,  GB GU4 8EW
Applicant Contact OLLIVER, PHD
Correspondent
MERCIA DIAGNOSTICS LTD.
MERCIA HOUSEET
BROADFORD PARK
GUILDFORD, SURREY ENGLAND,  GB GU4 8EW
Correspondent Contact OLLIVER, PHD
Regulation Number866.3830
Classification Product Code
LIP  
Date Received04/05/1988
Decision Date 08/04/1988
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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