BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    TOX PERFECT A TUBE

    K Number: K953393 · Decision Oct 6, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    3
    Applicant Total
    7
    Review Days
    84

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    Basic Information

    Device Name
    TOX PERFECT A TUBE
    K Number
    K953393
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.3280
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Chimera Research & Chemical, Inc.
    Date Received
    July 14, 1995
    Decision Date
    October 6, 1995
    Product Code
    DMP
    Advisory Committee
    Clinical Toxicology
    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
    DMP Digoxin Control Serum, Ria

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