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

    MULTI ANALYTE LINEARITY SET

    K Number: K936245 · Decision Oct 4, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    672
    Applicant Total
    51
    Review Days
    278

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    Basic Information

    Device Name
    MULTI ANALYTE LINEARITY SET
    K Number
    K936245
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Teco Diagnostics
    Date Received
    December 30, 1993
    Decision Date
    October 4, 1994
    Product Code
    JJY
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JJY Multi-Analyte Controls, All Kinds (Assayed)

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