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

    S-MONOVETTE EDTA K2-GEL

    K Number: K031359 · Decision Sep 12, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    7
    Applicant Total
    6
    Review Days
    135

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    Basic Information

    Device Name
    S-MONOVETTE EDTA K2-GEL
    K Number
    K031359
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sarstedt, Inc.
    Date Received
    April 30, 2003
    Decision Date
    September 12, 2003
    Product Code
    PJE
    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
    PJE Blood/Plasma Collection Device For Dna Testing

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