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

    RERMCO TEST CHLORIDE REAGENT

    K Number: K823106 · Decision Nov 16, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    18
    Applicant Total
    8
    Review Days
    26

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    Basic Information

    Device Name
    RERMCO TEST CHLORIDE REAGENT
    K Number
    K823106
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1170
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Fermco Biochemics, Inc.
    Date Received
    October 21, 1982
    Decision Date
    November 16, 1982
    Product Code
    JFS
    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
    JFS Coulometric, Chloride

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    Other Clearances by Fermco Biochemics, Inc.

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    K791066 GLUCOSE GOD-PAP TRINDER METHOD TEST KIT
    K791018 FERMCOTEST R BUN RATE REAGENT TEST KIT
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