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510(k) Data Aggregation

    K Number
    K011348
    Device Name
    PHASE II GBM IGG ANTIBODY EIA TEST
    Manufacturer
    SCIMEDX CORP.
    Date Cleared
    2001-06-25

    (54 days)

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

    SCIMEDX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K011082
    Device Name
    TPO IGG ANTIBODY EIA TEST
    Manufacturer
    SCIMEDX CORP.
    Date Cleared
    2001-06-06

    (57 days)

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

    SCIMEDX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K010625
    Device Name
    EUROSPITAL EU-TTG IGA UMANA
    Manufacturer
    SCIMEDX CORP.
    Date Cleared
    2001-04-24

    (53 days)

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

    SCIMEDX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K010287
    Device Name
    SCIMEDX PHASE II PR3 IGG ANTIBODY EIA
    Manufacturer
    SCIMEDX CORP.
    Date Cleared
    2001-03-16

    (44 days)

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

    SCIMEDX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K010289
    Device Name
    SCIMEDX PHASE II MPO IGG ANTIBODY EIA
    Manufacturer
    SCIMEDX CORP.
    Date Cleared
    2001-03-07

    (35 days)

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

    SCIMEDX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K002169
    Device Name
    GLIADIN IGA ANTIBODY EIA DETECTION SYSTEM
    Manufacturer
    SCIMEDX CORP.
    Date Cleared
    2000-10-19

    (93 days)

    Product Code
    MST
    Regulation Number
    866.5750
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCIMEDX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K002189
    Device Name
    GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM
    Manufacturer
    SCIMEDX CORP.
    Date Cleared
    2000-10-19

    (92 days)

    Product Code
    MST
    Regulation Number
    866.5750
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCIMEDX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K002107
    Device Name
    IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL CORD (PUC)-EMA/PUC LGA.
    Manufacturer
    SCIMEDX CORP.
    Date Cleared
    2000-08-04

    (23 days)

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

    SCIMEDX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K994379
    Device Name
    EU-TTG IGA ELISA
    Manufacturer
    SCIMEDX CORP.
    Date Cleared
    2000-02-18

    (53 days)

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

    SCIMEDX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Eu-tTG®IgA assay is a qualitative ELISA test for the in vitro diagnostic detection of IgA antibody against the enzyme tissue Transglutaminase in human serum. This test is designed for use as an aid in the diagnosis of Celiac Disease.
    Device Description
    Enzyme Immunoassay Kit
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    K Number
    K970198
    Device Name
    IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES
    Manufacturer
    SCIMEDX CORP.
    Date Cleared
    1997-02-20

    (30 days)

    Product Code
    DHN
    Regulation Number
    866.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCIMEDX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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