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

    CALIBRATING MATERIAL, CAL-PAK, BUFFERS

    K Number: K020894 · Decision Apr 29, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    134
    Registration Numbers
    134
    Same Product Code
    244
    Applicant Total
    2
    Review Days
    41

    Basic Information

    Device Name
    CALIBRATING MATERIAL, CAL-PAK, BUFFERS
    K Number
    K020894
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1150
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    MISSION DIAGNOSTICS
    Date Received
    March 19, 2002
    Decision Date
    April 29, 2002
    Product Code
    JIT
    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
    JIT Calibrator, Secondary

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (JIT), ordered by most recent decision date.

    VITROS Immunodiagnostic Products Insulin Calibrators

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CalSet IGF-1

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Abbott ARCHITECT Free T3

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Lumipulse G Progesterone-N Calibrators

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Lumipulse G FSH-N Calibrators

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Lumipulse G LH Calibrators

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry
    View all

    Other Clearances by MISSION DIAGNOSTICS

    K Number Device Name
    K022027 CALIBRATING MATERIAL, BUFFERS, STANDARD