LogoFDA 510(k) Search
Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K964385
    Device Name
    ELIAS ANA-HEP-2
    Manufacturer
    ELIAS USA, INC.
    Date Cleared
    1997-03-06

    (122 days)

    Product Code
    LJM
    Regulation Number
    866.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELIAS USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K963291
    Device Name
    VARELISA ANA (4) PROFILE
    Manufacturer
    ELIAS USA, INC.
    Date Cleared
    1996-09-30

    (40 days)

    Product Code
    LJM
    Regulation Number
    866.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELIAS USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K953873
    Device Name
    VARELISA HELICOBACTER PYLORI ANTIBODIES
    Manufacturer
    ELIAS USA, INC.
    Date Cleared
    1996-08-30

    (379 days)

    Product Code
    LYR
    Regulation Number
    866.3110
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELIAS USA, INC.

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

    Page 1 of 1