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

    STERICHEK PERACETIC ACID REAGENT STRIPS

    K Number: K980164 · Decision Apr 16, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    12
    Applicant Total
    8
    Review Days
    90

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    Basic Information

    Device Name
    STERICHEK PERACETIC ACID REAGENT STRIPS
    K Number
    K980164
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5665
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Environmental Test Systems, Inc.
    Date Received
    January 16, 1998
    Decision Date
    April 16, 1998
    Product Code
    MSY
    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
    MSY Strip, Test, Reagent, Residuals For Dialysate, Disinfectant

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    Other Clearances by Environmental Test Systems, Inc.

    K Number Device Name
    K031267 STERICHEK BICARB PH REAGENT STRIPS
    K003615 STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS
    K001194 STERICHEK TOTAL CHLORINE REAGENT STRIPS
    K994226 STERICHEK TOTAL CHLORINE REAGENT STRIPS
    K983997 STERICHEK TOTAL CHLORINE TEST KIT
    K974798 STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS
    K971598 STERICHEK CHLORINE REAGENT STRIPS