LogoFDA 510(k) Search
Search Filters

Search Results

Found 6 results

510(k) Data Aggregation

    K Number
    K001481
    Device Name
    PALCERAM 49
    Manufacturer
    AUREX SA (PTY) LTD.
    Date Cleared
    2000-06-23

    (43 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    AUREX SA (PTY) LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K001482
    Device Name
    AURENORM 75 KF
    Manufacturer
    AUREX SA (PTY) LTD.
    Date Cleared
    2000-06-23

    (43 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    AUREX SA (PTY) LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K001479
    Device Name
    PALCERAM 53
    Manufacturer
    AUREX SA (PTY) LTD.
    Date Cleared
    2000-06-21

    (41 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    AUREX SA (PTY) LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K001480
    Device Name
    AURECAST 40 B
    Manufacturer
    AUREX SA (PTY) LTD.
    Date Cleared
    2000-06-21

    (41 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    AUREX SA (PTY) LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K001477
    Device Name
    AURELUX Y 84 PREMIUM
    Manufacturer
    AUREX SA (PTY) LTD.
    Date Cleared
    2000-06-20

    (40 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    AUREX SA (PTY) LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K001478
    Device Name
    AURECAST SUPER INLAY
    Manufacturer
    AUREX SA (PTY) LTD.
    Date Cleared
    2000-06-20

    (40 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    AUREX SA (PTY) LTD.

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

    Page 1 of 1