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

    REDI-SCREEN

    K Number: K000979 · Decision Apr 10, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    48
    Applicant Total
    6
    Review Days
    14

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    Basic Information

    Device Name
    REDI-SCREEN
    K Number
    K000979
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.3610
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Redwood Biotech, Inc.
    Date Received
    March 27, 2000
    Decision Date
    April 10, 2000
    Product Code
    LAF
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LAF Gas Chromatography, Methamphetamine

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    Other Clearances by Redwood Biotech, Inc.

    K Number Device Name
    K993100 REDI-SCREEN
    K991698 REDI-TEST PCP
    K991110 REDI-TEST COCAINE
    K991504 REDI-TEST METHAMPHETAMINE
    K990870 REDI-TEST THC