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

    KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KIT

    K Number: K111956 · Decision May 30, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    0
    Applicant Total
    11
    Review Days
    324

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    Basic Information

    Device Name
    KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KIT
    K Number
    K111956
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Kronus Market Development Associates, Inc.
    Date Received
    July 11, 2011
    Decision Date
    May 30, 2012
    Product Code
    PAF
    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
    PAF Voltage Gated Calcium Channel (Vgcc) Antibody Assay

    Other Clearances by Kronus Market Development Associates, Inc.

    K Number Device Name
    DEN140001 ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KIT
    K121046 STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT
    K080523 KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KIT
    K080159 KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT
    K073590 KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT
    K072135 KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT
    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. →