BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)

    K Number: K161044 · Decision Jul 6, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    30
    Applicant Total
    7
    Review Days
    84

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    Basic Information

    Device Name
    AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)
    K Number
    K161044
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3610
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Assure Tech. (Hangzhou) Co, Ltd.
    Date Received
    April 13, 2016
    Decision Date
    July 6, 2016
    Product Code
    DJC
    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
    DJC Thin Layer Chromatography, Methamphetamine

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    Other Clearances by Assure Tech. (Hangzhou) Co, Ltd.

    K Number Device Name
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    K201630 AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests
    K181768 AssureTech Panel Dip Tests, AssureTech Quick Cup Tests
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    K170049 AssureTech Panel Dip Test, AssureTech Quick Cup Test
    K153465 AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup)