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

    COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM

    K Number: K050821 · Decision Aug 16, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    13
    Applicant Total
    1
    Review Days
    138

    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
    COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM
    K Number
    K050821
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5400
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zycare
    Date Received
    March 31, 2005
    Decision Date
    August 16, 2005
    Product Code
    KQG
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KQG Instrument, Coagulation

    Similar 510(k) Clearances

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

    FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON

    FDA 510(k)
    FDA Class 2 ·Hematology

    PACIFIC HEMOSTASIS THROMBOSCREEN 400C

    FDA 510(k)
    FDA Class 2 ·Hematology

    PACIFIC HEMOSTASIS THROMBOSCREEN 200

    FDA 510(k)
    FDA Class 2 ·Hematology

    HEMOCHRON RESPONSE

    FDA 510(k)
    FDA Class 2 ·Hematology

    ELVI 828 DIGICLOT MULTISCAN

    FDA 510(k)
    FDA Class 2 ·Hematology

    CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER

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