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

    ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD; ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE

    K Number: K020313 · Decision May 8, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    224
    Applicant Total
    6
    Review Days
    98

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    Basic Information

    Device Name
    ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD; ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE
    K Number
    K020313
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3100
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Acon Laboratories Co.
    Date Received
    January 30, 2002
    Decision Date
    May 8, 2002
    Product Code
    DKZ
    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
    DKZ Enzyme Immunoassay, Amphetamine

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    Other Clearances by Acon Laboratories Co.

    K Number Device Name
    K090057 ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEM
    K061559 ACON URINALYSIS REAGENT STRIPS
    K023766 ACON STREP A TWIST TEST DEVICE
    K010582 ACON STREP A RAPID TEST STRIP
    K980736 ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST