BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ALLERGENTICS TOTAL IGE/THEOPHYLLINE

    K Number: K842970 · Decision Aug 29, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    672
    Applicant Total
    8
    Review Days
    30

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    Basic Information

    Device Name
    ALLERGENTICS TOTAL IGE/THEOPHYLLINE
    K Number
    K842970
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Allergenetics
    Date Received
    July 30, 1984
    Decision Date
    August 29, 1984
    Product Code
    JJY
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JJY Multi-Analyte Controls, All Kinds (Assayed)

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    Other Clearances by Allergenetics

    K Number Device Name
    K851512 ALLERGENETICS IGE FAST TEST
    K842969 ALLERGENETICS ALLER-SPECIFIC IGE SERUM
    K833418 CHYMOFAST TEST
    K834594 TOTAL IGE FAST TEST
    K833419 LABELED 125I ANTI-IGE
    K834244 THEOFAST TEST KIT FOR QUANTITATIVE THEO
    K822341 ALLERGENETICS IGE-FAST TEST