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510(k) Data Aggregation

    K Number
    K012576
    Device Name
    CIC-C1Q EIA
    Manufacturer
    AMERICAN LABORATORY PRODUCTS CO., LTD.
    Date Cleared
    2002-01-29

    (173 days)

    Product Code
    DAK
    Regulation Number
    866.5240
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERICAN LABORATORY PRODUCTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CIC-C1q EIA is intended for the quantitative determination of circulating immune complexes (CIC) in serum or plasma.
    Device Description
    Not Found
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    K Number
    K011415
    Device Name
    ALPCO MILENIA ANTI-TG EIA
    Manufacturer
    AMERICAN LABORATORY PRODUCTS CO., LTD.
    Date Cleared
    2001-05-30

    (22 days)

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

    AMERICAN LABORATORY PRODUCTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K011201
    Device Name
    ALPCO MILENIA ANTI-TPO ELISA
    Manufacturer
    AMERICAN LABORATORY PRODUCTS CO., LTD.
    Date Cleared
    2001-05-24

    (35 days)

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

    AMERICAN LABORATORY PRODUCTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K974701
    Device Name
    ORGENTEC ANTI-MPO (P-ANCA) ELISA
    Manufacturer
    AMERICAN LABORATORY PRODUCTS CO., LTD.
    Date Cleared
    1998-02-17

    (71 days)

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

    AMERICAN LABORATORY PRODUCTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The anti-MPO indirect solid phase enzyme immunometric assay (ELISA) is designed for the semiquantitative measurement of IgG class autoantibodies directed against myeloperoxidase (MPO) and to aid in the diagnosis of microscopic polyangiitis and progressive glomerulonephritis.
    Device Description
    Not Found
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    K Number
    K974702
    Device Name
    ORGENTEC ANTI-PR3 (C-ANCA) ELISA
    Manufacturer
    AMERICAN LABORATORY PRODUCTS CO., LTD.
    Date Cleared
    1998-02-17

    (71 days)

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

    AMERICAN LABORATORY PRODUCTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The anti-PR3 indirect solid phase enzyme immunometric assay (ELISA) is designed for the semiquantitative measurement of IgG class autoantibodies directed against proteinase 3 (PR3) and to aid in the diagnosis of autoimmune vasculitides such as Wegener's granulomatosis.
    Device Description
    Not Found
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    K Number
    K972190
    Device Name
    THYROGLOBULIN ASSAY SYSTEM
    Manufacturer
    AMERICAN LABORATORY PRODUCTS CO., LTD.
    Date Cleared
    1997-07-14

    (56 days)

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

    AMERICAN LABORATORY PRODUCTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Thyroglobulin ELISA Assay is intended for the quantitative determination of thyroglobulin (TG) in human serum or plasma in patients who do not have TG antibodies; to aid in confirming the diagnosis of thyroid diseases, such as Graves' Disease; and to monitor for the absence of thyroglobulin in thyroidectomized patients.
    Device Description
    Not Found
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    K Number
    K970932
    Device Name
    ORGENTEC MICRO-ALBUMIN EIA ASSAY
    Manufacturer
    AMERICAN LABORATORY PRODUCTS CO., LTD.
    Date Cleared
    1997-04-08

    (47 days)

    Product Code
    JIR
    Regulation Number
    862.1645
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERICAN LABORATORY PRODUCTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K962057
    Device Name
    ORGENTEC ANTI-RNP/SM ELISA
    Manufacturer
    AMERICAN LABORATORY PRODUCTS CO., LTD.
    Date Cleared
    1996-11-18

    (174 days)

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

    AMERICAN LABORATORY PRODUCTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K962062
    Device Name
    ORGENTEC ANTI-SM ELISA
    Manufacturer
    AMERICAN LABORATORY PRODUCTS CO., LTD.
    Date Cleared
    1996-11-18

    (174 days)

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

    AMERICAN LABORATORY PRODUCTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K962052
    Device Name
    ORGENTEC ABTI-SS-BB(LA) ELISA
    Manufacturer
    AMERICAN LABORATORY PRODUCTS CO., LTD.
    Date Cleared
    1996-11-15

    (171 days)

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

    AMERICAN LABORATORY PRODUCTS CO., LTD.

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

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