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

    HCG MIDSTREAM PREGNANCY TEST

    K Number: K945568 · Decision Jan 17, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    225
    Applicant Total
    7
    Review Days
    68

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    Basic Information

    Device Name
    HCG MIDSTREAM PREGNANCY TEST
    K Number
    K945568
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Mizuho USA, Inc.
    Date Received
    November 10, 1994
    Decision Date
    January 17, 1995
    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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    Other Clearances by Mizuho USA, Inc.

    K Number Device Name
    K060825 MULTI-USE ELECTRONIC PREGNANCY TEST
    K043231 PROOF POSITIVE ELECTRONIC PREGNANCY TEST
    K000844 ABSOLUTE HCG PREGNANCY TEST
    K964002 NATURALE HCG PREGNANCY TES
    K943859 QUICK CHECKER HCG PREGNANCY TEST
    K931997 HCG MIDSTREAM PREGNANCY TEST