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

    DRUG STANDARDS

    K Number: K833276 · Decision Jan 1, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    93
    Applicant Total
    24
    Review Days
    101

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    Basic Information

    Device Name
    DRUG STANDARDS
    K Number
    K833276
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3200
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Supelco, Inc.
    Date Received
    September 22, 1983
    Decision Date
    January 1, 1984
    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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    K881868 LIQUID CHROMATOGRAPHY COLUMNS HISEP COLUMN & GUARD
    K881361 SOLID PHASE EXTRACTION TUBES
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    Search all 24 clearances from Supelco, Inc. →