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510(k) Data Aggregation

    K Number
    K001607
    Device Name
    REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)
    Manufacturer
    REPROMEDIX CORP.
    Date Cleared
    2000-10-05

    (134 days)

    Product Code
    CDP
    Regulation Number
    862.1710
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    REPROMEDIX CORP.

    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

    K Number
    K001603
    Device Name
    REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105)
    Manufacturer
    REPROMEDIX CORP.
    Date Cleared
    2000-10-05

    (134 days)

    Product Code
    KLI
    Regulation Number
    862.1700
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    REPROMEDIX CORP.

    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

    K Number
    K001606
    Device Name
    REPROBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 107)
    Manufacturer
    REPROMEDIX CORP.
    Date Cleared
    2000-10-05

    (134 days)

    Product Code
    JLW
    Regulation Number
    862.1690
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    REPROMEDIX CORP.

    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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