BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇱 Israel

    LIQUID TDM CONTROLS

    K Number: K871788 · Decision Jun 17, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    201
    Applicant Total
    2
    Review Days
    42

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    Basic Information

    Device Name
    LIQUID TDM CONTROLS
    K Number
    K871788
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.3280
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Biological Industries
    Date Received
    May 6, 1987
    Decision Date
    June 17, 1987
    Product Code
    DIF
    Advisory Committee
    Clinical Toxicology
    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
    DIF Drug Mixture Control Materials

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    Other Clearances by Biological Industries

    K Number Device Name
    K872376 LIPID CONTROL SERUM