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

    CHEMMATE(TM) KAPPA

    K Number: K950150 · Decision Oct 27, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    62
    Applicant Total
    6
    Review Days
    283

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    Basic Information

    Device Name
    CHEMMATE(TM) KAPPA
    K Number
    K950150
    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
    January 17, 1995
    Decision Date
    October 27, 1995
    Product Code
    DFH
    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
    DFH Kappa, Antigen, Antiserum, Control

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    Other Clearances by Biotek Solutions, Inc.

    K Number Device Name
    K950148 CHEMMATE(TM) CD43
    K936111 CHEMMATE SPECIAL STAIN LCA-CD45
    K950149 CHEMMATE(TM) LAMBDA
    K950152 CHEMMATE(TM) UCHL1 (CD45-RO)
    K950151 CHEMMATE(TM) L26 (CD20)