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

    ELVI 828 DIGICLOT MULTISCAN

    K Number: K902614 · Decision Nov 8, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    13
    Applicant Total
    9
    Review Days
    148

    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
    ELVI 828 DIGICLOT MULTISCAN
    K Number
    K902614
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5400
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Logos Scientific, Inc.
    Date Received
    June 13, 1990
    Decision Date
    November 8, 1990
    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.

    COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    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

    CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER

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

    Other Clearances by Logos Scientific, Inc.

    K Number Device Name
    K843375 ELVI 655 FLAME PHOTOMETER
    K844710 EUROCHIMA SERUM PROTEIN ELECTROPHORESIS METHOD
    K843296 ELVI 675 DIGITRON
    K842313 ELVI 146 SEROSCAN
    K842056 ELVI 165 PROTEO SEROSKOP
    K841804 ELVI 70 SAFETY CHAMBER
    K840757 ELVI 444 BILITRON
    K841288 ELVI 18