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510(k) Data Aggregation

    K Number
    DEN140001
    Device Name
    ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KIT
    Manufacturer
    KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
    Date Cleared
    2014-08-20

    (65 days)

    Product Code
    PHF
    Regulation Number
    866.5670
    Why did this record match?
    Applicant Name (Manufacturer) :

    KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KRONUS Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay is for the semi-quantitative determination of autoantibodies to Zinc Transporter 8 (ZnT8) in human serum. The KRONUS Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay may be useful as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes). The ZnT8Ab assay is not to be used alone and is to be used in conjunction with other clinical and laboratory findings.
    Device Description
    The KRONUS Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay contains the following: strip wells coated with ZnT8 (96 wells in total) and supplied as 12 strips of 8 wells in a frame and sealed in a foil bag with desiccant; ready-to-use 4 levels of calibrators (10, 20, 75, and 500 U/mL, 5x0.7 mL each); one each ready-to-use positive I, positive II and negative control serum (1x0.7 mL); Zinc T8 Biotin (lyophilized) 3x5.5 mL (reconstituted); ready-to-use reconstitution buffer for Zinc T8 Biotin 2x15 mL (colored red); Streptavidin Peroxidase (SA-POD dilute before use) 1x0.7 mL; ready-to-use diluent for SA-POD 1x15 mL; ready-to-use peroxidase substrate (TMB) 1x15 mL; concentrated wash solution (dilute with deionized water before use) 1x125 mL and ready-to-use stop solution 1x12 mL.
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    K Number
    K121046
    Device Name
    STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT
    Manufacturer
    KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
    Date Cleared
    2012-12-20

    (258 days)

    Product Code
    PCG
    Regulation Number
    866.5660
    Why did this record match?
    Applicant Name (Manufacturer) :

    KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KRONUS 21-Hydroxylase Antibody (21-OHAb) RIA Assay Kit is for the semiquantitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. The KRONUS Steroid 21-OHAb RIA Assay may be useful as an aid in the diagnosis of autoimmune adrenal disease, whether expressed as autoimmune Addison's disease (isolated) or Addison's disease as part of the more complex autoimmune polyglandular syndrome (APS), type I or II. The assay result is to be used in conjunction with other clinical and laboratory findings and is not a substitute for functional testing required to diagnose adrenal insufficiency.
    Device Description
    Not Found
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    K Number
    K111956
    Device Name
    KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KIT
    Manufacturer
    KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
    Date Cleared
    2012-05-30

    (324 days)

    Product Code
    PAF
    Regulation Number
    866.5660
    Why did this record match?
    Applicant Name (Manufacturer) :

    KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KRONUS Voltage Gated Calcium Channel (VGCC) Antibody RIA Assay Kit is for the semiquantitative determination of antibodies to voltage gated calcium channels in human serum. The VGCC antibody may be present in patients diagnosed with Lambert-Eaton Myasthenic Syndrome (LEMS). The assay result is not to be used alone and is to be used in conjunction with other clinical, electrodiagnostic and laboratory findings.
    Device Description
    Not Found
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    K Number
    K080523
    Device Name
    KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KIT
    Manufacturer
    KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
    Date Cleared
    2008-06-17

    (112 days)

    Product Code
    NST
    Regulation Number
    866.5660
    Why did this record match?
    Applicant Name (Manufacturer) :

    KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KRONUS Blocking AChRAb RIA Assay Kit is for the semi-quantitative determination of blocking antibodies to the acetylcholine receptor in human serum. The KRONUS Blocking AChRAb Assay is useful as an aid in the diagnosis of myasthenia gravis (MG).
    Device Description
    Not Found
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    K Number
    K080159
    Device Name
    KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT
    Manufacturer
    KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
    Date Cleared
    2008-05-22

    (120 days)

    Product Code
    JZO
    Regulation Number
    866.5870
    Why did this record match?
    Applicant Name (Manufacturer) :

    KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KRONUS TRAb ELISA Assay Kit is for the semi-quantitative determination of antibodies to the thyroid stimulating hormone receptor in human serum. The KRONUS TRAb ELISA Assay is useful as an aid in the diagnosis of Graves' Disease in conjunction with other clinical and laboratory findings.
    Device Description
    Not Found
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    K Number
    K073590
    Device Name
    KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT
    Manufacturer
    KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
    Date Cleared
    2008-04-10

    (112 days)

    Product Code
    OIF
    Regulation Number
    866.5660
    Why did this record match?
    Applicant Name (Manufacturer) :

    KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KRONUS IA-2 Autoantibody RIA Assay Kit is for the semi-quantitative determination of antibodies to tyrosine phosphatase (1A-2) in human serum. The KRONUS IA-2 Autoantibody RIA Assay is useful as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes).
    Device Description
    Not Found
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    K Number
    K072135
    Device Name
    KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT
    Manufacturer
    KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
    Date Cleared
    2007-11-07

    (97 days)

    Product Code
    NWG
    Regulation Number
    866.5660
    Why did this record match?
    Applicant Name (Manufacturer) :

    KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K070183
    Device Name
    KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT
    Manufacturer
    KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
    Date Cleared
    2007-07-13

    (175 days)

    Product Code
    OCN
    Regulation Number
    866.5660
    Why did this record match?
    Applicant Name (Manufacturer) :

    KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KRONUS Insulin Autoantibody RIA Assay Kit is for the semi-quantitative determination of antibodies to insulin in human serum. The KRONUS Insulin Autoantibody RIA Assay is useful as an aid in the diagnosis of Type I diabetes mellitus (autoimmune mediated diabetes) in patients who have not received insulin therapy.
    Device Description
    Not Found
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    K Number
    K051061
    Device Name
    KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KIT
    Manufacturer
    KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
    Date Cleared
    2005-11-04

    (192 days)

    Product Code
    NWG
    Regulation Number
    866.5660
    Why did this record match?
    Applicant Name (Manufacturer) :

    KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KRONUS GADAb RIA Assay Kit is for the semi-quantitative determination of glutamic acid decarboxylase antibody in human serum. The KRONUS GADAb RIA Assay is useful as an aid in the diagnosis of Type I diabetes mellitus (autoimmune mediated diabetes).
    Device Description
    KRONUS Glutamic Acid Decarboxylase (GADAb) RIA Assay Kit
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    K Number
    K042248
    Device Name
    KRONUS, INC.'S ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAB) ASSAY KIT
    Manufacturer
    KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
    Date Cleared
    2004-12-17

    (120 days)

    Product Code
    NST
    Regulation Number
    866.5660
    Why did this record match?
    Applicant Name (Manufacturer) :

    KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KRONUS Acetylcholine Receptor Antibody (AChRAb) Assay Kit is for the quantitative or qualitative determination of acetylcholine receptor antibody in human serum. The KRONUS Acetylcholine Receptor Antibody(AChRAb) kit is useful as an aid in the differential diagnosis of Myasthenia Gravis.
    Device Description
    Not Found
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