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

    Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx

    K Number: K221871 · Decision Aug 30, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    29
    Applicant Total
    3
    Review Days
    63

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    Basic Information

    Device Name
    Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx
    K Number
    K221871
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3100
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Healstone Biotech, Inc.
    Date Received
    June 28, 2022
    Decision Date
    August 30, 2022
    Product Code
    NFT
    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
    NFT Test, Amphetamine, Over The Counter

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    Other Clearances by Healstone Biotech, Inc.

    K Number Device Name
    K212418 hCG One Step Pregnancy Test
    K191841 Accurate Multi Panel Drug Urine Test Cup