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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, toxoplasma gondii
510(k) Number K880918
Device Name CAPTIA TOXO-G
Applicant
MERCIA DIAGNOSTICS LTD.
mercia houseet
broadford park
guildford, surrey england,  GB gu4 8ew
Applicant Contact olliver
Correspondent
MERCIA DIAGNOSTICS LTD.
mercia houseet
broadford park
guildford, surrey england,  GB gu4 8ew
Correspondent Contact olliver
Regulation Number866.3780
Classification Product Code
LGD  
Date Received03/04/1988
Decision Date 08/01/1988
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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