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

    ABNORMAL URINE CONTROL

    K Number: K833191 · Decision Dec 8, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    672
    Applicant Total
    10
    Review Days
    80

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    Basic Information

    Device Name
    ABNORMAL URINE CONTROL
    K Number
    K833191
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Biosan Laboratories, Inc.
    Date Received
    September 19, 1983
    Decision Date
    December 8, 1983
    Product Code
    JJY
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JJY Multi-Analyte Controls, All Kinds (Assayed)

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    Other Clearances by Biosan Laboratories, Inc.

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    K833193 RADIOIMMUNOASSAY, THYROID STIMU. HORMONE
    K834023 BIO-SCIENCE LABORATORIES T4 REAGENT
    K833318 NORMAL GOAT SERUM
    K833192 NORMAL URINE CONTROL
    K833320 AMBERLITE CG50 RESIN, 100-200 MESH
    K833319 BIO-REX 70 RESIN 100-200 MESH PH6.2