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

    ATOMSPEC GF BLOOD LEAD WORKSTATION

    K Number: K936060 · Decision Sep 6, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    260

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    Basic Information

    Device Name
    ATOMSPEC GF BLOOD LEAD WORKSTATION
    K Number
    K936060
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3550
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Thermo Jarrell Ash Corp.Div.Thermo Inst.
    Date Received
    December 20, 1993
    Decision Date
    September 6, 1994
    Product Code
    DOF
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DOF Lead, Atomic Absorption

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