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

    EMDS(TM) ELEVATED BILIRUBIN CALIBRATOR # 67627/95

    K Number: K862704 · Decision Aug 19, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    72
    Registration Numbers
    72
    Same Product Code
    129
    Applicant Total
    288
    Review Days
    35

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    Basic Information

    Device Name
    EMDS(TM) ELEVATED BILIRUBIN CALIBRATOR # 67627/95
    K Number
    K862704
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1150
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Em Diagnostic Systems, Inc.
    Date Received
    July 15, 1986
    Decision Date
    August 19, 1986
    Product Code
    JIS
    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
    JIS Calibrator, Primary

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    K935174 TOTAL PROTEIN TEST (TPRO)
    K935177 GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST
    K935136 CHOLESTEROL (CHOL) TEST ITEM NO. 65410
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