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

    STRATUS VITAMIN B12 FLUOROMETRIC ENZYME-LINKED

    K Number: K924074 · Decision Oct 26, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    77
    Applicant Total
    72
    Review Days
    75

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    Basic Information

    Device Name
    STRATUS VITAMIN B12 FLUOROMETRIC ENZYME-LINKED
    K Number
    K924074
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1810
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Baxter Diagnostics, Inc.
    Date Received
    August 12, 1992
    Decision Date
    October 26, 1992
    Product Code
    CDD
    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
    CDD Radioassay, Vitamin B12

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