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510(k) Data Aggregation

    K Number
    K981364
    Device Name
    PYRILINKS-D ASSAY KIT
    Manufacturer
    METRA BIOSYSTEMS, INC.
    Date Cleared
    1998-08-13

    (120 days)

    Product Code
    JMM
    Regulation Number
    862.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    METRA BIOSYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Measurement of Dpd is intended for use as an aid in monitoring bone resorption changes in postmenopausal women receiving hormonal or bisphosphonate antiresorptive therapies and in individuals diagnosed with osteoporosis.
    Device Description
    Not Found
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    K Number
    K981373
    Device Name
    ALKPHASE-B ASSAY KIT
    Manufacturer
    METRA BIOSYSTEMS, INC.
    Date Cleared
    1998-05-27

    (41 days)

    Product Code
    CIN
    Regulation Number
    862.1050
    Why did this record match?
    Applicant Name (Manufacturer) :

    METRA BIOSYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Measurement of BAP is intended for use as an aid in the: management of postmenopausal osteoporosis and Paget's disease. monitoring of postmenopausal women on hormonal or bisphosphonate therapy prediction of skeletal response to hormonal therapy in postmenopausal women.
    Device Description
    Not Found
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    K Number
    K974260
    Device Name
    PYRILINKS-D ASSAY KIT
    Manufacturer
    METRA BIOSYSTEMS, INC.
    Date Cleared
    1998-01-26

    (74 days)

    Product Code
    JMM
    Regulation Number
    862.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    METRA BIOSYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pyrilinks-D is a urinary assay that provides a quantitative measure of the excretion of deoxypyridinoline (Dpd) crosslinks as an indicator of bone resorption. Elevated levels of urinary Dpd indicate elevated bone resorption in individuals. Measurement of Dpd is intended for use in monitoring bone resorption changes in postmenopausal women receiving antiresorptive therapies and in individuals diagnosed with osteoporosis.
    Device Description
    Not Found
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