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

    ALBUMIN PROCEDURE BCP

    K Number: K832632 · Decision Sep 12, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    17
    Applicant Total
    23
    Review Days
    39

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    Basic Information

    Device Name
    ALBUMIN PROCEDURE BCP
    K Number
    K832632
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1035
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Sandare Chemical Co., Inc.
    Date Received
    August 4, 1983
    Decision Date
    September 12, 1983
    Product Code
    CJW
    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
    CJW Bromcresol Purple Dye-Binding, Albumin

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    Other Clearances by Sandare Chemical Co., Inc.

    K Number Device Name
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    K862556 SANDARE GLYCOHEMOGLOBIN PROCEDURE
    K860684 SANDARE BCG ALBUMIN PROCEDURE
    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
    K832183 SANDARE CALCIUM PROCEDURE
    Search all 23 clearances from Sandare Chemical Co., Inc. →