BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT

    K Number: K080159 · Decision May 22, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    91
    Applicant Total
    11
    Review Days
    120

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    Basic Information

    Device Name
    KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT
    K Number
    K080159
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5870
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Kronus Market Development Associates, Inc.
    Date Received
    January 23, 2008
    Decision Date
    May 22, 2008
    Product Code
    JZO
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JZO System, Test, Thyroid Autoantibody

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    Other Clearances by Kronus Market Development Associates, Inc.

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    K080523 KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KIT
    K073590 KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT
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    K070183 KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT
    K051061 KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KIT
    K042248 KRONUS, INC.'S ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAB) ASSAY KIT
    K032134 TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT
    Search all 11 clearances from Kronus Market Development Associates, Inc. →