BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    PICCOLO METLYTE 7 REAGENT DISC

    K Number: K992140 · Decision Aug 26, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    2
    Applicant Total
    20
    Review Days
    63

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    Basic Information

    Device Name
    PICCOLO METLYTE 7 REAGENT DISC
    K Number
    K992140
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1210
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Abaxis, Inc.
    Date Received
    June 24, 1999
    Decision Date
    August 26, 1999
    Product Code
    JLB
    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
    JLB Atp And Creatine Kinase (Enzymatic), Creatine

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