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

    SUREVUE URINE HCG

    K Number: K010522 · Decision Jul 31, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    374
    Applicant Total
    199
    Review Days
    159

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    Basic Information

    Device Name
    SUREVUE URINE HCG
    K Number
    K010522
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sa Scientific, Inc.
    Date Received
    February 22, 2001
    Decision Date
    July 31, 2001
    Product Code
    JHI
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    TX
    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 Sa Scientific, Inc.

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    K030628 SAS RSV CONTROL KIT
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