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    FDA 510(k), K883147, TRACE ELEMENTS SERUM TOXICOLOGY CONTROL

    FDA 510(k), K883147, TRACE ELEMENTS SERUM TOXICOLOGY CONTROL

    $89.00 USD
    $89.00 USD
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    FAST TRACK NOT AVAILABLE SINCE FIRST PARTY

    510(K) Number: K883147
    Device Name: TRACE ELEMENTS SERUM TOXICOLOGY CONTROL
    Manufacturer: LAWRENCE B PLUTCHAK
    Device Classification Name: Multi-Analyte Controls, All Kinds (Assayed)
    Regulation Number: JJY
    Classification Product Code: KXA
    Date Received: 07/26/1988
    Decision Date: 10/06/1988
    Decision: Substantially Equivalent (SESE)
    Regulation Medical Specialty: Toxicology
    • Status: Pending Fast-Track Request
    • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

    NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.

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