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

    SYNCHRON SYUSTEMS DAT DRUG FREE URINE CONTROL

    K Number: K971534 · Decision May 21, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    201
    Applicant Total
    6
    Review Days
    23

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    Basic Information

    Device Name
    SYNCHRON SYUSTEMS DAT DRUG FREE URINE CONTROL
    K Number
    K971534
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.3280
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beckman
    Date Received
    April 28, 1997
    Decision Date
    May 21, 1997
    Product Code
    DIF
    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
    DIF Drug Mixture Control Materials

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    Other Clearances by Beckman

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    K935362 P-AMYLASE CONTROL
    K904219 SYNCHRON CX 7 CLINICAL ANALYZER
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