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

    FETAL D TECTION KIT

    K Number: K980314 · Decision Apr 8, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    4
    Review Days
    71

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    Basic Information

    Device Name
    FETAL D TECTION KIT
    K Number
    K980314
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7455
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Biopool Intl., Inc.
    Date Received
    January 27, 1998
    Decision Date
    April 8, 1998
    Product Code
    LIM
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LIM Test, Screening, For D Positive Fetal Rbc'S

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