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

    ELECTRA 800 AUTOMATIC COAGULATION TIMER

    K Number: K851169 · Decision Jun 24, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    13
    Applicant Total
    17
    Review Days
    94

    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
    ELECTRA 800 AUTOMATIC COAGULATION TIMER
    K Number
    K851169
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5400
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Medical Laboratory Automation Systems, Inc.
    Date Received
    March 22, 1985
    Decision Date
    June 24, 1985
    Product Code
    KQG
    Advisory Committee
    Hematology
    Review Advisory Committee
    PA
    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

    ELVI 828 DIGICLOT MULTISCAN

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

    Other Clearances by Medical Laboratory Automation Systems, Inc.

    K Number Device Name
    K962664 ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER
    K944227 ELECTRA 1400C AUTOMATIC COAGULATION ANALYZER
    K931206 ELECTRA 1600C AUTOMATIC COAGULATION TIMER
    K923220 THROMBIN CLOT TIME TEST PROCEDURE
    K903638 GASTRO-INTESTINAL ACCU-CULSHURE TM
    K903405 CHLAMYDIA ACCU-CULSHURE TM
    K903406 VIRAL ACCU-CULSHURE TM
    K901645 ANAEROBIC ACCU-CULSHURE(TM)
    K894052 ELECTRA 1000C AUTOMATIC COAGULATION TIMER
    K884863 ELECTRA 900C AUTOMATIC COAGULATION TIMER
    Search all 17 clearances from Medical Laboratory Automation Systems, Inc. →