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

    POTENCY TEST STRIPS, INDICATOR TEST STRIPS

    K Number: K974426 · Decision Feb 10, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    56
    Applicant Total
    6
    Review Days
    471

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    Basic Information

    Device Name
    POTENCY TEST STRIPS, INDICATOR TEST STRIPS
    K Number
    K974426
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Reprocessing Products Corp
    Date Received
    October 27, 1997
    Decision Date
    February 10, 1999
    Product Code
    LIF
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LIF Dialyzer Reprocessing System

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    Other Clearances by Reprocessing Products Corp

    K Number Device Name
    K123805 E-Z CHEK BLOOD LEAK TEST STRIPS
    K101750 RPC E-Z CHEK 6.8-8.5 PH TEST STRIPS, MODEL K100-0117 AND E-Z CHEK 0-14 PH TEST STRIPS, MODEL K100-0104
    K090338 ULTRA LOW TOTAL CHLORINE, E-Z CHEK SENSITIVE TOTAL CHLORINE
    K974064 MICRO X RESIDUAL TEST STRIPS
    K950602 PORT CAPS (PROTECTIVE CLOSURES FOE REPROCESSED HEMODIALYZERS