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

    LEADCARE BLOOD LEAD TESTING SYSTEM

    K Number: K971640 · Decision Sep 9, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    5
    Applicant Total
    7
    Review Days
    130

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    Basic Information

    Device Name
    LEADCARE BLOOD LEAD TESTING SYSTEM
    K Number
    K971640
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3550
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Esa, Inc.
    Date Received
    May 2, 1997
    Decision Date
    September 9, 1997
    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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