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

    ULTRAZYME PLUS CK-1

    K Number: K780100 · Decision Mar 9, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    122
    Applicant Total
    116
    Review Days
    48

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    Basic Information

    Device Name
    ULTRAZYME PLUS CK-1
    K Number
    K780100
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Harleco
    Date Received
    January 20, 1978
    Decision Date
    March 9, 1978
    Product Code
    CGS
    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
    CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes

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    Other Clearances by Harleco

    K Number Device Name
    K820233 ULTRAZYME PLUS GAMMA GT(65055-65056)
    K813427 ULTRACHEM GLUC-DH
    K813042 ULTRACHEM GLUC-DH SET, ITEM #65048
    K813039 ULTRACHEM E-CHOL, ITEM #65025
    K813043 ULTRACHEM CREA ITEM #64972
    K813040 ULTRACHEM CA, ITEM #64975
    K813044 ULTRACHEM ALB, ITEM #64970
    K813041 ULTRAZYME-GT, ITEM #64959 & 65032
    K813038 ULTRACHEM TP, ITEM #64974
    K812593 ULTRA ZYME PLUS CK-1 #64978, 65027 & 28
    Search all 116 clearances from Harleco →