BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇲🇽 Mexico

    THROMBOSTIN IFA*

    K Number: K885107 · Decision Jun 23, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    126
    Applicant Total
    24
    Review Days
    193

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    Basic Information

    Device Name
    THROMBOSTIN IFA*
    K Number
    K885107
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7750
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Investigacion Farmaceutica S.A. DE C.V.
    Date Received
    December 12, 1988
    Decision Date
    June 23, 1989
    Product Code
    GJS
    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
    GJS Test, Time, Prothrombin

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    Other Clearances by Investigacion Farmaceutica S.A. DE C.V.

    K Number Device Name
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    K892713 IFA SENSIBAC NALIDIXIC ACID
    K892735 IFA SENSIBAC CEPHALOTIN
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    K885112 BRUCELLA IFA*
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    K885113 IFA* POSITIVE AND NEGATIVE ANTIGENS CONTROL
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