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

    STERICHEK BICARB PH REAGENT STRIPS

    K Number: K031267 · Decision Dec 23, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    5
    Applicant Total
    8
    Review Days
    246

    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
    STERICHEK BICARB PH REAGENT STRIPS
    K Number
    K031267
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Environmental Test Systems, Inc.
    Date Received
    April 21, 2003
    Decision Date
    December 23, 2003
    Product Code
    MNV
    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
    MNV Strip, Dialysate Ph Indicator

    Similar 510(k) Clearances

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

    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

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MITEK MINI ANCHOR

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MITEK ABSORBABLE ANCHOR

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ABSORBALBE ANCHOR

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SERIM(TM) BICARB PH REAGENT STRIPS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Environmental Test Systems, Inc.

    K Number Device Name
    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
    K980164 STERICHEK PERACETIC ACID REAGENT STRIPS
    K974798 STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS
    K971598 STERICHEK CHLORINE REAGENT STRIPS