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

    SANDARE CYANMETHEMOGLOBIN STANDARD

    K Number: K792358 · Decision Dec 31, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    24
    Applicant Total
    23
    Review Days
    40

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    Basic Information

    Device Name
    SANDARE CYANMETHEMOGLOBIN STANDARD
    K Number
    K792358
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.8165
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Sandare Chemical Co., Inc.
    Date Received
    November 21, 1979
    Decision Date
    December 31, 1979
    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 Sandare Chemical Co., Inc.

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    K851395 SANDARE IRON-BINDING CAPACITY PROCEDURE
    K851394 SANDARE IRON PROCEDURE
    K844498 SANDARE ALKALINE PHOSPHATASE PROCEDURE
    K842516 SANDARE ACID PHOSPHATASE PROCEDURE
    K833898 TRI-LEVEL BILIRUBIN CONTROLS
    K832942 TOTAL & DIRECT BILIRUBIN PROCEDURES
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