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

    IRON/TIBC REAGENT

    K Number: K935712 · Decision Sep 20, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    66
    Applicant Total
    7
    Review Days
    659

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    Basic Information

    Device Name
    IRON/TIBC REAGENT
    K Number
    K935712
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1410
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Horizon Diagnostics, Inc.
    Date Received
    November 30, 1993
    Decision Date
    September 20, 1995
    Product Code
    JIY
    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
    JIY Photometric Method, Iron (Non-Heme)

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    Other Clearances by Horizon Diagnostics, Inc.

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    K930678 AMYLASE
    K934533 BUN-300/BUN-500 UREA NITROGEN REAGENT
    K930679 DIRECT BILIRUBIN
    K930074 IN-VITRO DIAGNOSTIC REAGENT SET