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

    IDS PORPHYRIN REAGENT

    K Number: K812859 · Decision Oct 26, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    243
    Applicant Total
    11
    Review Days
    13

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    Basic Information

    Device Name
    IDS PORPHYRIN REAGENT
    K Number
    K812859
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Innovative Diagnostic Systems, Inc.
    Date Received
    October 13, 1981
    Decision Date
    October 26, 1981
    Product Code
    JTO
    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
    JTO Discs, Strips And Reagents, Microorganism Differentiation

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