BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    ADAMS A1c HA-8180V, CALIBRATOR 80

    K Number: K162822 · Decision Jun 29, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    25
    Applicant Total
    6
    Review Days
    265

    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
    ADAMS A1c HA-8180V, CALIBRATOR 80
    K Number
    K162822
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1373
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Arkray Factory, Inc.
    Date Received
    October 7, 2016
    Decision Date
    June 29, 2017
    Product Code
    PDJ
    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
    PDJ Hemoglobin A1c Test System

    Similar 510(k) Clearances

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

    Medconn 8K Glycated Hemoglobin Test System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Medconn Glycated Hemoglobin Test system

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Hipro Glycosylated Hemoglobin (HbA1c) Test System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Tosoh Automated Glycohemoglobin Analyzer HLC-723G8

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay

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

    Other Clearances by Arkray Factory, Inc.

    K Number Device Name
    K183306 GLUCOCARD® W onyx Blood Glucose Monitoring System
    K170064 GLUCOCARD W Blood Glucose Monitoring System
    K142336 GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring System
    K142035 GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, RELION MICRO BLOOD GLUCOSE MONITORING SYSTEM
    K124021 ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEM