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510(k) Data Aggregation

    K Number
    K252195

    Validate with FDA (Live)

    Device Name
    ARTICOR planner
    Manufacturer
    Date Cleared
    2026-03-27

    (256 days)

    Product Code
    Regulation Number
    892.2050
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K260255

    Validate with FDA (Live)

    Date Cleared
    2026-03-27

    (58 days)

    Product Code
    Regulation Number
    878.4400
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251273

    Validate with FDA (Live)

    Date Cleared
    2026-03-27

    (337 days)

    Product Code
    Regulation Number
    884.1700
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K254161

    Validate with FDA (Live)

    Date Cleared
    2026-03-27

    (95 days)

    Product Code
    Regulation Number
    892.2060
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K260273

    Validate with FDA (Live)

    Date Cleared
    2026-03-26

    (56 days)

    Product Code
    Regulation Number
    870.1130
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K260274

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2026-03-25

    (55 days)

    Product Code
    Regulation Number
    888.3030
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    Device Description
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    K Number
    K254278

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2026-03-25

    (85 days)

    Product Code
    Regulation Number
    870.1200
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252169

    Validate with FDA (Live)

    Device Name
    Access BNP II
    Date Cleared
    2026-03-24

    (257 days)

    Product Code
    Regulation Number
    862.1117
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252031

    Validate with FDA (Live)

    Date Cleared
    2026-03-23

    (266 days)

    Product Code
    Regulation Number
    872.3640
    Panel
    Dental
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K260561

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2026-03-20

    (29 days)

    Product Code
    Regulation Number
    888.3040
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    Device Description
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