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

    PARASAFE(R) FIXATIVE

    K Number: K935316 · Decision Feb 17, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    12
    Applicant Total
    28
    Review Days
    107

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    Basic Information

    Device Name
    PARASAFE(R) FIXATIVE
    K Number
    K935316
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2900
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Scientific Device Laboratory, Inc.
    Date Received
    November 2, 1993
    Decision Date
    February 17, 1994
    Product Code
    LKS
    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
    LKS Device, Parasite Concentration

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