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

    BIONIKE A/Q PREGNANCY TEST

    K Number: K954901 · Decision Dec 11, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    374
    Applicant Total
    6
    Review Days
    47

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    Basic Information

    Device Name
    BIONIKE A/Q PREGNANCY TEST
    K Number
    K954901
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Bionike Laboratories, Inc.
    Date Received
    October 25, 1995
    Decision Date
    December 11, 1995
    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 Bionike Laboratories, Inc.

    K Number Device Name
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    K971841 BIONIKE AQ ONE STEP CANNABINOIDS (THC) TEST
    K971361 AQ OPIATES (MORPHINE) TEST
    K960992 BIONIKE A/Q PREGNANCY TEST