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

    DRYSLIDE COAGULASE

    K Number: K950706 · Decision May 16, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    11
    Applicant Total
    121
    Review Days
    90

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    Basic Information

    Device Name
    DRYSLIDE COAGULASE
    K Number
    K950706
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2160
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Difco Laboratories, Inc.
    Date Received
    February 15, 1995
    Decision Date
    May 16, 1995
    Product Code
    JTL
    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
    JTL Plasma, Coagulase, Human, Horse And Rabbit

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