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

    REDI-TEST THC

    K Number: K990870 · Decision Apr 27, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    149
    Applicant Total
    6
    Review Days
    42

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    Basic Information

    Device Name
    REDI-TEST THC
    K Number
    K990870
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3870
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Redwood Biotech, Inc.
    Date Received
    March 16, 1999
    Decision Date
    April 27, 1999
    Product Code
    LDJ
    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
    LDJ Enzyme Immunoassay, Cannabinoids

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    Other Clearances by Redwood Biotech, Inc.

    K Number Device Name
    K000979 REDI-SCREEN
    K993100 REDI-SCREEN
    K991698 REDI-TEST PCP
    K991110 REDI-TEST COCAINE
    K991504 REDI-TEST METHAMPHETAMINE