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

    CYTOTECH RUBELLA IGG ENZYME IMMUNOASSAY

    K Number: K864315 · Decision Feb 2, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    93
    Applicant Total
    10
    Review Days
    91

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    Basic Information

    Device Name
    CYTOTECH RUBELLA IGG ENZYME IMMUNOASSAY
    K Number
    K864315
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3510
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Cytotech, Inc.
    Date Received
    November 3, 1986
    Decision Date
    February 2, 1987
    Product Code
    LFX
    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
    LFX Enzyme Linked Immunoabsorbent Assay, Rubella

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    Other Clearances by Cytotech, Inc.

    K Number Device Name
    K882829 CIRCULATING IMMUNE COMPLEXES CONTROLS
    K874379 CIC-RAJI CELL REPLACEMENT ENZYME IMMUNOASSAY
    K873249 ANTINUCLEAR ANTIBODY (ANA) POSITIVE CONTROLS
    K872426 CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAY
    K871801 CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KIT
    K862838 CYTOTECH HSV IGG ENZYME IMMUNOASSAY
    K863363 CYTOTECH TOXOPLASMA IGG ENZYME IMMUNOASSAY
    K862649 CYTOTECH CIC ENZYME IMMUNOASSAY
    K860493 CYTOTECH CMV IGG EIA