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

    HIGH PERFORMANCE CALIBRATORS

    K Number: K875216 · Decision Jun 22, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    93
    Applicant Total
    6
    Review Days
    183

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    Basic Information

    Device Name
    HIGH PERFORMANCE CALIBRATORS
    K Number
    K875216
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3200
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Rapid Diagnostic Laboratories, Inc.
    Date Received
    December 22, 1987
    Decision Date
    June 22, 1988
    Product Code
    DKB
    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
    DKB Calibrators, Drug Mixture

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