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

    IFA* POSITIVE AND NEGATIVE ANTIGENS CONTROL

    K Number: K885113 · 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

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    Basic Information

    Device Name
    IFA* POSITIVE AND NEGATIVE ANTIGENS CONTROL
    K Number
    K885113
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3085
    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
    GSN
    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
    GSN Antiserum, Positive And Negative Febrile Antigen Control Serum

    Similar 510(k) Clearances

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    SAS FEBRILE POSITIVE & NEGATIVE CONTROL ANTISERUM

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    NEGATIVE CONTROL SERUM FOR CF RO ID

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    FDA Class 2 ·Microbiology
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    Other Clearances by Investigacion Farmaceutica S.A. DE C.V.

    K Number Device Name
    K892721 IFA SENSIBAC CEFACLOR
    K892728 IFA SENSIBAC NORFLOXACIN
    K892733 IFA SENSIBAC KANAMYCIN
    K892713 IFA SENSIBAC NALIDIXIC ACID
    K892735 IFA SENSIBAC CEPHALOTIN
    K892726 IFA SENSIBAC PENICILLIN
    K885112 BRUCELLA IFA*
    K892720 IFA SENSIBAC GENTAMYCIN
    K885110 PROTEUS OX-19 IFA*
    K885114 SALMONELLA IFA*
    Search all 24 clearances from Investigacion Farmaceutica S.A. DE C.V. →