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510(k) Data Aggregation

    K Number
    K251538
    Device Name
    Status™ COVID-19/Flu A&B
    Manufacturer
    Princeton BioMeditech Corp.
    Date Cleared
    2025-11-14

    (179 days)

    Product Code
    SCA
    Regulation Number
    866.3987
    Type
    Dual Track
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
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    K Number
    K252627
    Device Name
    Lyme-ID IgG Test; Bio-ID800
    Manufacturer
    Inanovate Inc.
    Date Cleared
    2025-11-14

    (86 days)

    Product Code
    LSR
    Regulation Number
    866.3830
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K250501
    Device Name
    System Sophi
    Manufacturer
    This AG
    Date Cleared
    2025-11-14

    (267 days)

    Product Code
    HQC
    Regulation Number
    886.4670
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251821
    Device Name
    ARC-EX System
    Manufacturer
    Onward Medical Inc.
    Date Cleared
    2025-11-14

    (154 days)

    Product Code
    SDO
    Regulation Number
    890.5851
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K250471
    Device Name
    AquaC UNO H
    Manufacturer
    Fresenius Medical Care Renal Therapies Group, LLC
    Date Cleared
    2025-11-14

    (269 days)

    Product Code
    FIP
    Regulation Number
    876.5665
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251872
    Device Name
    Biomoneta Avata Rx
    Manufacturer
    Biomoneta Research Private Limited
    Date Cleared
    2025-11-14

    (149 days)

    Product Code
    FRF
    Regulation Number
    880.5045
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
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    K Number
    K251756
    Device Name
    Sterilization Trays
    Manufacturer
    Paragon Implant Mfg., LLC
    Date Cleared
    2025-11-14

    (158 days)

    Product Code
    KCT
    Regulation Number
    880.6850
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K250865
    Device Name
    KLS Martin IPS Forearm System
    Manufacturer
    KLS-Martin L.P.
    Date Cleared
    2025-11-14

    (238 days)

    Product Code
    HRS,HWC,PBF
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
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    K Number
    K250525
    Device Name
    Second Opinion® Panoramic
    Manufacturer
    Pearl Inc.
    Date Cleared
    2025-11-14

    (266 days)

    Product Code
    MYN
    Regulation Number
    892.2070
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251078
    Device Name
    AutoDensity
    Manufacturer
    EOS imaging
    Date Cleared
    2025-11-14

    (220 days)

    Product Code
    QIH
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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