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

    ULTRA CHEM ALB

    K Number: K821880 · Decision Jul 14, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    119
    Applicant Total
    23
    Review Days
    19

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    Basic Information

    Device Name
    ULTRA CHEM ALB
    K Number
    K821880
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1035
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Harleco Diagnostics
    Date Received
    June 25, 1982
    Decision Date
    July 14, 1982
    Product Code
    CIX
    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
    CIX Bromcresol Green Dye-Binding, Albumin

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    Other Clearances by Harleco Diagnostics

    K Number Device Name
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    K821878 ULTRAZYME PLUS LDH
    K821873 ULTRACHEM T-BILI
    K821882 ULTRAZYME PLUS GPT
    K821877 ULTRAZYME PLUS HBD
    K821883 ULTRAZYME PLUS CK-I
    K821871 ULTRAZYME PLUS 2GT
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