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

    COAT-A-COUNT(TM) LSD RADIOIMMUNOASSAY KIT

    K Number: K891167 · Decision May 3, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    6
    Applicant Total
    321
    Review Days
    58

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    Basic Information

    Device Name
    COAT-A-COUNT(TM) LSD RADIOIMMUNOASSAY KIT
    K Number
    K891167
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3580
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Diagnostic Products Corp.
    Date Received
    March 6, 1989
    Decision Date
    May 3, 1989
    Product Code
    DLB
    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
    DLB Radioimmunoassay, Lsd (125-I)

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    K022603 IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER
    K022118 IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS)
    K021257 ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS)
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