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

    DISPENSER, TECHNETIUM, CLINTICHEM

    K Number: K770515 · Decision Apr 5, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    31
    Applicant Total
    69
    Review Days
    19

    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
    DISPENSER, TECHNETIUM, CLINTICHEM
    K Number
    K770515
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1360
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Union Carbide Corp.
    Date Received
    March 17, 1977
    Decision Date
    April 5, 1977
    Product Code
    KPT
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KPT Calibrator, Dose, Radionuclide

    Similar 510(k) Clearances

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

    CRC PC Smart Chamber K1

    FDA 510(k)
    FDA Class 2 ·Radiology

    CRC-77tHR

    FDA 510(k)
    FDA Class 2 ·Radiology

    Veenstra Instruments VDC-506 Dose Calibrator

    FDA 510(k)
    FDA Class 2 ·Radiology

    CRC PC WITH SMART CHAMBER

    FDA 510(k)
    FDA Class 2 ·Radiology

    CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TW

    FDA 510(k)
    FDA Class 2 ·Radiology

    ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336

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

    Other Clearances by Union Carbide Corp.

    K Number Device Name
    K830337 MARK III OXYGEN WALKER SYS-LOW PRESS
    K820836 MARK III OXYGEN WALKER SYSTEM
    K820535 LASER GAS MIXTURES
    K812536 LINDE MARK II
    K810732 LINDE MARK II OXYGEN RESERV. TYPE OR-4
    K810596 CENTRIFI CHEM SYSTEM 400 ANALYZER
    K810129 CENTRIFICHEM SYSTEM 500
    K803216 CENTRIFICHEM AST/SGOT OPTIMIZED REAGENT
    K802741 CENTRIFICHEM COMB. SERUM-BASED CALIB.
    K802520 CENTRIFICHEM PIPETTOR ACCURACY CALIB.
    Search all 69 clearances from Union Carbide Corp. →