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

    PICCOLO HDL-CAPILLARY TEST SYSTEM

    K Number: K120662 · Decision Apr 24, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    8
    Applicant Total
    20
    Review Days
    50

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    Basic Information

    Device Name
    PICCOLO HDL-CAPILLARY TEST SYSTEM
    K Number
    K120662
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1475
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Abaxis, Inc.
    Date Received
    March 5, 2012
    Decision Date
    April 24, 2012
    Product Code
    JHM
    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
    JHM Colorimetric Method, Lipoproteins

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    Other Clearances by Abaxis, Inc.

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    K120664 PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM
    K091052 PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM
    K091910 PICCOLO MAGNESIUM TEST SYSTEM
    K051108 PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM
    K040115 PICCOLO MAGNESIUM TEST SYSTEM
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