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

    TOTAL PROTEIN PROCEDURE

    K Number: K832169 · Decision Aug 16, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    115
    Applicant Total
    23
    Review Days
    41

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    TOTAL PROTEIN PROCEDURE
    K Number
    K832169
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1635
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Sandare Chemical Co., Inc.
    Date Received
    July 6, 1983
    Decision Date
    August 16, 1983
    Product Code
    CEK
    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
    CEK Biuret (Colorimetric), Total Protein

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (CEK), ordered by most recent decision date.

    HICHEM TOTAL PROTEIN REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CARESIDE TOTAL PROTEIN

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TOTAL PROTEIN OR TP

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CSF/URINE TOTAL PROTEIN

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry
    View all

    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
    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
    K832632 ALBUMIN PROCEDURE BCP
    Search all 23 clearances from Sandare Chemical Co., Inc. →