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

    PENICILLIN-STREPTOMYCIN-FUNGIZONE MIXTURE

    K Number: K861997 · Decision Jun 10, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    69
    Applicant Total
    47
    Review Days
    18

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    Basic Information

    Device Name
    PENICILLIN-STREPTOMYCIN-FUNGIZONE MIXTURE
    K Number
    K861997
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2450
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Hazleton Research Products, Inc.
    Date Received
    May 23, 1986
    Decision Date
    June 10, 1986
    Product Code
    JSK
    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
    JSK Supplement, Culture Media

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    K861874 MINIMUM ESSENTIAL MED. (EAGLE) W/25MM HEPES BUFFER
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