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

    FRUCTOSAMINE, MODEL FR 106-01

    K Number: K991246 · Decision Dec 16, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    65
    Same Product Code
    248
    Applicant Total
    18
    Review Days
    248

    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
    FRUCTOSAMINE, MODEL FR 106-01
    K Number
    K991246
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7470
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    A.P. Total Care, Inc.
    Date Received
    April 12, 1999
    Decision Date
    December 16, 1999
    Product Code
    LCP
    Advisory Committee
    Hematology
    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
    LCP Assay, Glycosylated Hemoglobin

    Similar 510(k) Clearances

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

    Nova Allegro HbA1c Assay, Nova Allegro Analyzer

    FDA 510(k)
    FDA Class 2 ·Hematology

    Q-Pad Test System

    FDA 510(k)
    FDA Class 2 ·Hematology

    Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer

    FDA 510(k)
    FDA Class 2 ·Hematology

    Aina HbA1c Monitoring System 2

    FDA 510(k)
    FDA Class 2 ·Hematology

    PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit

    FDA 510(k)
    FDA Class 2 ·Hematology

    OneDraw A1C Test System

    FDA 510(k)
    FDA Class 2 ·Hematology
    View all

    Other Clearances by A.P. Total Care, Inc.

    K Number Device Name
    K991762 ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02
    K991761 MAGNESIUM PRODUCT NO'S, 112-01, 112-02
    K991664 LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01
    K991665 HDL CHOLESTEROL, PRODUCT NO'S 124-01, CH102-01
    K991867 INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02
    K991866 BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04
    K991870 ELECTROLYTES (NA+, K+, CL-), PRODUCT NO'S 114-01, 114-02, 114-03
    K991663 AST/SGOT
    K991666 TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02
    K991247 URIC ACID, MODEL UA112-01
    Search all 18 clearances from A.P. Total Care, Inc. →