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

    EZ-SCREEN:HCG

    K Number: K902681 · Decision Aug 9, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    374
    Applicant Total
    6
    Review Days
    51

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    Basic Information

    Device Name
    EZ-SCREEN:HCG
    K Number
    K902681
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Environmental Diagnostics, Inc.
    Date Received
    June 19, 1990
    Decision Date
    August 9, 1990
    Product Code
    JHI
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JHI Visual, Pregnancy Hcg, Prescription Use

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    Other Clearances by Environmental Diagnostics, Inc.

    K Number Device Name
    K905700 EZ-SCREEN: AMPHETAMINES
    K905057 EZ-SCREEN:BARBITURATES
    K900203 EZ-SCREEN:OPIATES
    K883105 EZ-SCREEN CANNABINOID/COCAINE
    K862916 EZ-SCREEN: CANNABINOID