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

    CK-UV REAGENT

    K Number: K823211 · Decision Nov 22, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    37
    Applicant Total
    11
    Review Days
    25

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    Basic Information

    Device Name
    CK-UV REAGENT
    K Number
    K823211
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Biorent Diagnostic, Inc.
    Date Received
    October 28, 1982
    Decision Date
    November 22, 1982
    Product Code
    JHS
    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
    JHS Differential Rate Kinetic Method, Cpk Or Isoenzymes

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    Other Clearances by Biorent Diagnostic, Inc.

    K Number Device Name
    K832747 ALBUMIN REAGENT SET
    K823060 HEMOGLOBIN REAGENT
    K822494 OPTIMIZED UV-GPT REAGENT SET
    K822493 OPTIMIZED UV-GOT REAGENT SET
    K822492 OPTIMIZED UV-LDH REAGENT SET
    K820768 COLORIMETRIC LDH REAGENT SET
    K820632 COLORIMETRIC URIC ACID REAGENT SET
    K813555 GLUCOSE ENZYME-COLOR REAGENT SET
    K813244 UV URIC ACID DETERMINATION
    K811760 CHOLESTEROL DETERMINATION
    Search all 11 clearances from Biorent Diagnostic, Inc. →