BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC

    K Number: K060810 · Decision Aug 7, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    224
    Applicant Total
    8
    Review Days
    136

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    Basic Information

    Device Name
    ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC
    K Number
    K060810
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3100
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ind Diagnostic, Inc.
    Date Received
    March 24, 2006
    Decision Date
    August 7, 2006
    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 Ind Diagnostic, Inc.

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    K063390 URINE CHEMISTRY ANALYZER UR-50
    K052694 ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES.
    K052662 ONE STEP FSH MENOPAUSAL TEST
    K050741 IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT
    K023638 CASSETTE/URINE HCG