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Glycoproteins / Immune system / Immunologic tests / Immunology / Rubella / Immunoglobulin M / Immunoassay / Rheumatoid factor / Antibody / Biology / Medicine / Pediatrics


510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION EXECUTIVE SUMMARY A. 510(k) Number: k122397
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Document Date: 2012-10-09 13:29:38

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City

Stillwater / /

Company

MD 20993 DiaSorin Inc. / DiaSorin Inc. / K122397 Trade / /

Country

United States / /

Event

FDA Phase / /

IndustryTerm

in vitro diagnostic device / manufacturing / chemical reaction / /

Organization

FDA / Food and Drug Administration / DEPARTMENT OF HEALTH / African Union / /

Person

Carol DePouwv / Cosmetic Act (Act) / Expected Values / /

Position

SUBSTANTIAL EQUIVALENCE DETERMINATION EXECUTIVE / Calibrator / Major / /

Product

Gamma / EP5-A2 / A2 / EPO7-A2 / /

ProvinceOrState

Minnesota / /

Technology

flash / antibodies / Immunoassay technology / testing protocol / containing Rubella IgM antibodies / /

SocialTag