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

    ORTHO ALT MICROWELL TEST SYSTEM

    K Number: K941192 · Decision May 16, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    10
    Applicant Total
    126
    Review Days
    428

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    Basic Information

    Device Name
    ORTHO ALT MICROWELL TEST SYSTEM
    K Number
    K941192
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1030
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ortho Diagnostic Systems, Inc.
    Date Received
    March 14, 1994
    Decision Date
    May 16, 1995
    Product Code
    CKD
    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
    CKD Hydrazone Colorimetry, Alt/Sgpt

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