BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CHEMMATE SPECIAL STAIN LCA-CD45

    K Number: K936111 · Decision Feb 27, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    52
    Applicant Total
    6
    Review Days
    796

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    Basic Information

    Device Name
    CHEMMATE SPECIAL STAIN LCA-CD45
    K Number
    K936111
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5550
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biotek Solutions, Inc.
    Date Received
    December 23, 1993
    Decision Date
    February 27, 1996
    Product Code
    DEH
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DEH Lambda, Antigen, Antiserum, Control

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