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

    DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G)

    K Number: K033851 · Decision Mar 2, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    80
    Applicant Total
    9
    Review Days
    82

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    Basic Information

    Device Name
    DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G)
    K Number
    K033851
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1340
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hypoguard USA, Inc.
    Date Received
    December 11, 2003
    Decision Date
    March 2, 2004
    Product Code
    JIL
    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
    JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

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    Other Clearances by Hypoguard USA, Inc.

    K Number Device Name
    K053079 ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460001
    K051514 ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460002
    K041881 ADVANCE MICRO-DRAW BLOOD GLUCOSE MONITORING SYSTEM, MODEL 411100
    K031388 MODIFICATION TO HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM
    K024347 EXPRESS BLOOD GLUCOSE MONITORING SYSTEM
    K022545 GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 555020
    K020232 HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM
    K010973 DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00; DIASCREEN REAGENT STRIP FOR URINALYSIS, CAT. # D11000