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

    QM300 CONTROL G PACK

    K Number: K910887 · Decision Jun 17, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    36
    Applicant Total
    58
    Review Days
    105

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    Basic Information

    Device Name
    QM300 CONTROL G PACK
    K Number
    K910887
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3720
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Kallestad Diag, A Div. of Erbamont, Inc.
    Date Received
    March 4, 1991
    Decision Date
    June 17, 1991
    Product Code
    GTQ
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GTQ Antistreptolysin - Titer/Streptolysin O Reagent

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    Other Clearances by Kallestad Diag, A Div. of Erbamont, Inc.

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    K900009 NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SET
    K897072 NDS THYROXINE TEST KIT & NDS THYROXINE CALIBRATOR
    K894947 PLATELIA TOXO IGG KIT
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    Search all 58 clearances from Kallestad Diag, A Div. of Erbamont, Inc. →