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

    NEPHELOMETRIC SOLID TURBIDITY STANDARD

    K Number: K812220 · Decision Aug 18, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    16
    Applicant Total
    44
    Review Days
    12

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    Basic Information

    Device Name
    NEPHELOMETRIC SOLID TURBIDITY STANDARD
    K Number
    K812220
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1150
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Hyland Therapeutic Div., Travenol Laboratories
    Date Received
    August 6, 1981
    Decision Date
    August 18, 1981
    Product Code
    JIW
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JIW Calibrator, Surrogate

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    K802610 ALERT A,HDL-APOLIPOROTEIN A, TEST KIT
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    K790249 TEST CELLS
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