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

    PROFIBLOT

    K Number: K933996 · Decision Jan 28, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    82
    Registration Numbers
    82
    Same Product Code
    20
    Applicant Total
    6
    Review Days
    164

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    Basic Information

    Device Name
    PROFIBLOT
    K Number
    K933996
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.3800
    Medical Specialty
    Pathology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Tecan U.S., Ltd.
    Date Received
    August 17, 1993
    Decision Date
    January 28, 1994
    Product Code
    KPA
    Advisory Committee
    Pathology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KPA Slide Stainer, Automated

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