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

    REAGENTS FOR USE ON CONTRAVES DC300, DC500, AL801

    K Number: K873832 · Decision Nov 23, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    24
    Applicant Total
    15
    Review Days
    63

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    Basic Information

    Device Name
    REAGENTS FOR USE ON CONTRAVES DC300, DC500, AL801
    K Number
    K873832
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.8165
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    In Vitro Diagnostics, Inc.
    Date Received
    September 21, 1987
    Decision Date
    November 23, 1987
    Product Code
    KRZ
    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
    KRZ Calibrator For Hemoglobin And Hematocrit Measurement

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    Other Clearances by In Vitro Diagnostics, Inc.

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    K896865 VITRO T4-EIA-XT
    K896925 T UPTAKE ENZYME IMMUNOASSAY CRIMPED TUBE KIT
    K896864 FOLLICLE STIMULATING HORMONE-EIA-XT
    K871182 FLAME PHOTOMETER STANDARD #60081 120 NA/2K
    K871183 FLAME PHOTOMETER STANDARD #60082 140 NA/5K
    K871188 LITHIUM INTERNAL STANDARD 1500 MEQ/L #60086
    K871185 LITHIUM INTERNAL STANDARD 1 MEQ/L #60085
    Search all 15 clearances from In Vitro Diagnostics, Inc. →