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

    AC/AD LINEARITY VERIFIERS

    K Number: K982217 · Decision Jul 2, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    201
    Applicant Total
    3
    Review Days
    8

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    Basic Information

    Device Name
    AC/AD LINEARITY VERIFIERS
    K Number
    K982217
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.3280
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sc Calibrators & Controls, LLC
    Date Received
    June 24, 1998
    Decision Date
    July 2, 1998
    Product Code
    DIF
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    Y

    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 Sc Calibrators & Controls, LLC

    K Number Device Name
    K973790 ABC LINEARITY VERIFIERS
    K973791 ABC CALIBRATION VERIFIERS