BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    QUALICHECK 3

    K Number: K904733 · Decision Nov 2, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    66
    Applicant Total
    50
    Review Days
    16

    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
    QUALICHECK 3
    K Number
    K904733
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Radiometer America, Inc.
    Date Received
    October 17, 1990
    Decision Date
    November 2, 1990
    Product Code
    JJS
    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
    JJS Controls For Blood-Gases, (Assayed And Unassayed)

    Similar 510(k) Clearances

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

    CueSee Hypoxic

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Hematocrit and Metabolite QUALICHECK

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    HIGH METABOLITE QUALICHECK

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MISSION CONTROLS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 AND 3, MODEL 507, 508, 509

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry
    View all

    Other Clearances by Radiometer America, Inc.

    K Number Device Name
    K153712 VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit
    K992859 ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE
    K991417 ABL 735 ANALYZER
    K982928 NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM
    K980130 ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM
    K980135 QUALICHECK5+ MODELS S7730, S7740, S7750, S7760
    K974818 ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM
    K973367 ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM
    K962158 PICO MODELS 30, 50, 70
    K962334 EML105 ELECTROLYTE METABOLITE ANALYZER
    Search all 50 clearances from Radiometer America, Inc. →