BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    OXALATE URINE CONTROLS (NORMAL AND ELEVATED)

    K Number: K062521 · Decision Mar 16, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    244
    Applicant Total
    2
    Review Days
    200

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    OXALATE URINE CONTROLS (NORMAL AND ELEVATED)
    K Number
    K062521
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1150
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Thermo-Electron Corp.
    Date Received
    August 28, 2006
    Decision Date
    March 16, 2007
    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 Thermo-Electron Corp.

    K Number Device Name
    K052056 DATA-TROL N NORMAL CONTROL SERUM, DATA-TROL A ABNORMAL CONTROL SERUM