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

    REDI-TEST PCP

    K Number: K991698 · Decision Aug 25, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    87
    Applicant Total
    6
    Review Days
    99

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    Basic Information

    Device Name
    REDI-TEST PCP
    K Number
    K991698
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Redwood Biotech, Inc.
    Date Received
    May 18, 1999
    Decision Date
    August 25, 1999
    Product Code
    LCM
    Advisory Committee
    Unknown
    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
    LCM Enzyme Immunoassay, Phencyclidine

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    Other Clearances by Redwood Biotech, Inc.

    K Number Device Name
    K000979 REDI-SCREEN
    K993100 REDI-SCREEN
    K991110 REDI-TEST COCAINE
    K991504 REDI-TEST METHAMPHETAMINE
    K990870 REDI-TEST THC