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510(k) Data Aggregation

    K Number
    K051297
    Device Name
    ELECSYS N-MID OSTEOCALCIN, ELECSYS OSTEOCALCIN CALSET, ELECSYS OSTEOCALCIN CALCHECK
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Date Cleared
    2005-09-08

    (113 days)

    Product Code
    NEO,JIT,JJX
    Regulation Number
    862.1050
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Product Code :

    NEO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K003609
    Device Name
    N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000
    Manufacturer
    OSTEOMETER BIOTECH A/S
    Date Cleared
    2001-05-16

    (175 days)

    Product Code
    NEO
    Regulation Number
    862.1050
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Product Code :

    NEO

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

    Ask a specific question about this device

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