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

    SANDARE IRON-BINDING CAPACITY PROCEDURE

    K Number: K851395 · Decision May 7, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    45
    Applicant Total
    23
    Review Days
    28

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    Basic Information

    Device Name
    SANDARE IRON-BINDING CAPACITY PROCEDURE
    K Number
    K851395
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1415
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Sandare Chemical Co., Inc.
    Date Received
    April 9, 1985
    Decision Date
    May 7, 1985
    Product Code
    JMO
    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
    JMO Ferrozine (Colorimetric) Iron Binding Capacity

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    Other Clearances by Sandare Chemical Co., Inc.

    K Number Device Name
    K872852 EAGLE DIAGNOSTICS GLYCOHEMOGLOBIN UNITIZED TEST
    K862556 SANDARE GLYCOHEMOGLOBIN PROCEDURE
    K860684 SANDARE BCG ALBUMIN 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
    K832632 ALBUMIN PROCEDURE BCP
    K832183 SANDARE CALCIUM PROCEDURE
    Search all 23 clearances from Sandare Chemical Co., Inc. →