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

    DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00; DIASCREEN REAGENT STRIP FOR URINALYSIS, CAT. # D11000

    K Number: K010973 · Decision Sep 11, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    80
    Applicant Total
    9
    Review Days
    162

    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
    DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00; DIASCREEN REAGENT STRIP FOR URINALYSIS, CAT. # D11000
    K Number
    K010973
    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
    April 2, 2001
    Decision Date
    September 11, 2001
    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)

    Similar 510(k) Clearances

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

    AUTION MAX AX-4060 Urinalysis System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    cobas u 601 urinalysis test system

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DIP/U.S. Urine Analysis Test System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    inui In-Home Urine Analysis Test System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DUS R-50S (Urine Chemistry system)

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

    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
    K033851 DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G)
    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