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

    BLOOD SPECIMEN COLLECTION DEVICES

    K Number: K863491 · Decision Oct 24, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    235
    Applicant Total
    15
    Review Days
    46

    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
    BLOOD SPECIMEN COLLECTION DEVICES
    K Number
    K863491
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Medelec Intl. Corp.
    Date Received
    September 8, 1986
    Decision Date
    October 24, 1986
    Product Code
    JKA
    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
    JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

    Similar 510(k) Clearances

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

    Female Culture Device; Male Culture Device; Transfer Device; Access Device

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached Holder

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection Tube

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Steripath® Flow™ Blood Collection System

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

    Other Clearances by Medelec Intl. Corp.

    K Number Device Name
    K961013 DISPOSABLE NEEDLE ELECTRODE
    K935017 TD50 ELECTROMYOGRAPH
    K922548 MEDELEC 2110 AND 2114 EEG
    K920127 ELECTROENCEPHALOGRAPH RECORDING SYSTEM
    K912775 SAPPHIRE 4ME EMG/EP SYSTEM
    K865106 PROPHYLACTIC (CONDOM) MR. JOHNNY
    K854622 PROPHYLACTIC (CONDOM)
    K854562 CONNECTOR, BLOOD TUBING, INFUSION T. INTRAVENOUS I
    K854860 BLADES, SCALPEL CARBON STEET
    K854858 SCALPEL HANDLE
    Search all 15 clearances from Medelec Intl. Corp. →