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

    URIC ACID TEST ITEM NUMBER 65422

    K Number: K932162 · Decision Sep 27, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    30
    Applicant Total
    288
    Review Days
    146

    Basic Information

    Device Name
    URIC ACID TEST ITEM NUMBER 65422
    K Number
    K932162
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1775
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    EM DIAGNOSTIC SYSTEMS, INC.
    Date Received
    May 4, 1993
    Decision Date
    September 27, 1993
    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.)

    Similar 510(k) Clearances

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

    RANDOX URIC ACID

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100P

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    URIC ACID

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    URIC ACID

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry
    View all

    Other Clearances by EM DIAGNOSTIC SYSTEMS, INC.

    K Number Device Name
    K935181 ASPARTATE AMINOTRANSFERASE (AST) TEST
    K935180 ALANINE AMINOTRANSFERASE (ALT) TEST
    K935178 EMDS PHOSPHOROUS (PHOS) TEST
    K935179 EMDS ALBUMIN (ALB) TEST
    K935174 TOTAL PROTEIN TEST (TPRO)
    K935136 CHOLESTEROL (CHOL) TEST ITEM NO. 65410
    K935175 LACTATE DEHYDROGENASE (LD)
    K935177 GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST
    K935176 IRON TEST
    K935183 EMDS MAGNESIUM (MG) TEST
    Search all 288 clearances from EM DIAGNOSTIC SYSTEMS, INC. →