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

    ABSOLUTE HCG PREGNANCY TEST

    K Number: K000844 · Decision Jun 16, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    71
    Applicant Total
    7
    Review Days
    93

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    Basic Information

    Device Name
    ABSOLUTE HCG PREGNANCY TEST
    K Number
    K000844
    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
    March 15, 2000
    Decision Date
    June 16, 2000
    Product Code
    DHA
    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
    DHA System, Test, Human Chorionic Gonadotropin

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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
    K964002 NATURALE HCG PREGNANCY TES
    K943859 QUICK CHECKER HCG PREGNANCY TEST
    K945568 HCG MIDSTREAM PREGNANCY TEST
    K931997 HCG MIDSTREAM PREGNANCY TEST