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

    OLYMPUS URIC ACID REAGENT

    K Number: K955752 · Decision Jan 31, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    30
    Applicant Total
    149
    Review Days
    43

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    Basic Information

    Device Name
    OLYMPUS URIC ACID REAGENT
    K Number
    K955752
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1775
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Olympus America, Inc.
    Date Received
    December 19, 1995
    Decision Date
    January 31, 1996
    Product Code
    CDO
    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
    CDO Acid, Uric, Uricase (U.V.)

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    Other Clearances by Olympus America, Inc.

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    K073490 OLYMPUS IGG REAGENT
    K073489 OLYMPUS IGA REAGENT
    K062862 OLYMPUS URIC ACID REAGENT, MODEL OSR6X98
    K063804 OLYMPUS TRIGLYCERIDE TEST SYSTEM
    K061499 OSFERION
    K062581 OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM
    K061575 OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117
    Search all 149 clearances from Olympus America, Inc. →