BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    CIBA CORNING MODEL 644

    K Number: K875098 · Decision Mar 3, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    28
    Applicant Total
    125
    Review Days
    84

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    Basic Information

    Device Name
    CIBA CORNING MODEL 644
    K Number
    K875098
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2850
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Ciba Corning Diagnostics Corp.
    Date Received
    December 10, 1987
    Decision Date
    March 3, 1988
    Product Code
    JXR
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JXR Atomic Absorption Spectrophotometer, General Use

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    Other Clearances by Ciba Corning Diagnostics Corp.

    K Number Device Name
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    K961657 CIBA CORNING 400 SYSTEM
    K962021 CIBA CORNING 348 SYSTEM
    K962126 ACS CKMB II IMMUNOASSAY
    K962041 ACS LH2 IMMUNOASSAY
    K961510 ACS FRT4 IMMUNOASSAY
    K960246 LIQUID CARDIAC MARKER 1,2,3 ASSAYED
    K955873 ACS PHENYTOIN ASSAY
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