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

    MIDSTREAM ONESTEP PREGNANCY HOME TEST

    K Number: K963341 · Decision Dec 2, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    225
    Applicant Total
    26
    Review Days
    98

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    Basic Information

    Device Name
    MIDSTREAM ONESTEP PREGNANCY HOME TEST
    K Number
    K963341
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Syntron Bioresearch, Inc.
    Date Received
    August 26, 1996
    Decision Date
    December 2, 1996
    Product Code
    LCX
    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
    LCX Kit, Test, Pregnancy, Hcg, Over The Counter

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    K981292 QUIKPAC II ONE STEP PHENCYCLIDINE (PCP) TEST
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