BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇲🇽 Mexico

    PROTEUS OX-19 IFA*

    K Number: K885110 · Decision Aug 15, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    2
    Applicant Total
    24
    Review Days
    246

    Basic Information

    Device Name
    PROTEUS OX-19 IFA*
    K Number
    K885110
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3410
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    INVESTIGACION FARMACEUTICA S.A. DE C.V.
    Date Received
    December 12, 1988
    Decision Date
    August 15, 1989
    Product Code
    GSZ
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GSZ Antigens, Febrile (Weil-Felix), All Groups

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (GSZ), ordered by most recent decision date.

    FEBRILE ANTIGEN CONTROL SERA

    FDA 510(k)
    FDA Class 1 ·Microbiology

    FEBRILE ANTIGENS & CONTROL SERUMS

    FDA 510(k)
    FDA Class 1 ·Microbiology
    View all

    Other Clearances by INVESTIGACION FARMACEUTICA S.A. DE C.V.

    K Number Device Name
    K892721 IFA SENSIBAC CEFACLOR
    K892728 IFA SENSIBAC NORFLOXACIN
    K892713 IFA SENSIBAC NALIDIXIC ACID
    K892733 IFA SENSIBAC KANAMYCIN
    K892735 IFA SENSIBAC CEPHALOTIN
    K892720 IFA SENSIBAC GENTAMYCIN
    K885112 BRUCELLA IFA*
    K885114 SALMONELLA IFA*
    K885113 IFA* POSITIVE AND NEGATIVE ANTIGENS CONTROL
    K892726 IFA SENSIBAC PENICILLIN
    Search all 24 clearances from INVESTIGACION FARMACEUTICA S.A. DE C.V. →