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510(k) Data Aggregation

    K Number
    K060578
    Device Name
    CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION)
    Manufacturer
    SCANTIBODIES LABORATORY, INC.
    Date Cleared
    2006-08-30

    (177 days)

    Product Code
    JKR
    Regulation Number
    862.1140
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCANTIBODIES LABORATORY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Scantibodies Laboratory Inc. Calcitonin test system is a device intended to measure the thyroid hormone calcitonin (thryocalcitonin) levels in serum. Calcitonin measurements are used in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism (excessive activity of the parathyroid gland).
    Device Description
    Calcitonin Immunoradiometric Assay (IRMA) (Coated Tube Version)
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    K Number
    K060420
    Device Name
    MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA) ASSAY KIT, MODEL 3KG002
    Manufacturer
    SCANTIBODIES LABORATORY, INC.
    Date Cleared
    2006-03-01

    (12 days)

    Product Code
    CEW
    Regulation Number
    862.1545
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCANTIBODIES LABORATORY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Scantibodies Laboratory, inc. Whole Parathyroid Hormone (PTH) test system is a device intended to measure parathyroid hormone in plasma. PTH measurements are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.
    Device Description
    Whole PTH (1-84) ImmunoChemiluminoMetric (ICMA) Assay
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    K Number
    K060348
    Device Name
    MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT
    Manufacturer
    SCANTIBODIES LABORATORY, INC.
    Date Cleared
    2006-02-27

    (17 days)

    Product Code
    CEW
    Regulation Number
    862.1545
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCANTIBODIES LABORATORY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Scantibodies Laboratory, Inc. Total Intact Parathyroid Hormone (PTH) test system is a device intended to measure parathyroid hormone in plasma. Measurements of a crother incone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.
    Device Description
    Total Intact PTH ImmunoChemiluminoMetric (ICMA) Assay
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    K Number
    K051888
    Device Name
    TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013
    Manufacturer
    SCANTIBODIES LABORATORY, INC.
    Date Cleared
    2005-10-18

    (98 days)

    Product Code
    CEW
    Regulation Number
    862.1545
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCANTIBODIES LABORATORY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Scantibodies Laboratory, Inc. Total Intact Parathyroid Hormone (PTH) test system is a device intended to measure the levels of parathyroid hormone in serum and plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.
    Device Description
    Total Intact PTH Immunoradiometric Assay (Coated Tube Version)
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    K Number
    K051810
    Device Name
    WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT, MODEL 3KG014
    Manufacturer
    SCANTIBODIES LABORATORY, INC.
    Date Cleared
    2005-09-09

    (66 days)

    Product Code
    CEW
    Regulation Number
    862.1545
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCANTIBODIES LABORATORY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Scantibodies Laboratory, Inc. Whole Parathyroid Hormone (PTH) test system is a device intended to measure parathyroid hormone in plasma and serum. PTH measurements are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.
    Device Description
    Not Found
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    K Number
    K051141
    Device Name
    WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILUMINOMETRIC ASSAY (ICMA), MODEL 3KG002
    Manufacturer
    SCANTIBODIES LABORATORY, INC.
    Date Cleared
    2005-07-26

    (83 days)

    Product Code
    CEW
    Regulation Number
    862.1545
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCANTIBODIES LABORATORY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Scantibodies Laboratory, Inc. Whole Parathyroid Hormone (PTH) test system is a device intended to measure parathyroid hormone in plasma. PTH measurements are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.
    Device Description
    Not Found
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    K Number
    K051150
    Device Name
    TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT
    Manufacturer
    SCANTIBODIES LABORATORY, INC.
    Date Cleared
    2005-07-26

    (83 days)

    Product Code
    CEW
    Regulation Number
    862.1545
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCANTIBODIES LABORATORY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Scantibodies Laboratory, Inc. Total Intact Parathyroid Hormone (PTH) test system is a device intended to measure parathyroid hormone in plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.
    Device Description
    Not Found
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    K Number
    K050748
    Device Name
    ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011
    Manufacturer
    SCANTIBODIES LABORATORY, INC.
    Date Cleared
    2005-05-20

    (59 days)

    Product Code
    CKG
    Regulation Number
    862.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCANTIBODIES LABORATORY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Scantibodies Laboratory, Inc. Adrenocorticotropic Hormone (ACTH) test system is a device intended to measure adrenocorticotropic hormone in plasma. ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands, such as Cushing's syndrome, and the ectopic ACTH syndrome.
    Device Description
    ACTH Immunoradiometric (IRMA) Assay
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    K Number
    K031534
    Device Name
    CYCLASE ACTIVATING PTH (CAP) IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG001
    Manufacturer
    SCANTIBODIES LABORATORY, INC.
    Date Cleared
    2003-07-30

    (75 days)

    Product Code
    CEW
    Regulation Number
    862.1545
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCANTIBODIES LABORATORY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A parathyroid hormone test system is a device intended to measure the levels of parathyroid hormone in serum and plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.
    Device Description
    Parathyroid Hormone (PTH) Immunoradiometric IRMA Assay
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    K Number
    K021032
    Device Name
    ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100
    Manufacturer
    SCANTIBODIES LABORATORY, INC.
    Date Cleared
    2002-06-03

    (66 days)

    Product Code
    CKG
    Regulation Number
    862.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCANTIBODIES LABORATORY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Scantibodies Laboratory, Inc. Adrenocorticotropic Hormone (ACTH) test system is a device intended to measure adrenocorticotropic hormone in plasma. ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands, such as Cushing's syndrome, adrenocortical insufficiency and the ectopic ACTH syndrome.
    Device Description
    ACTH Immunoradiometric (IRMA) Assav
    Ask a Question

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