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

    ACCURACY

    K Number: K854119 · Decision Oct 25, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    672
    Applicant Total
    2
    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
    ACCURACY
    K Number
    K854119
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Columbia Diagnostics, Inc.
    Date Received
    October 9, 1985
    Decision Date
    October 25, 1985
    Product Code
    JJY
    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
    JJY Multi-Analyte Controls, All Kinds (Assayed)

    Similar 510(k) Clearances

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

    Multichem IA Plus

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Audit MicroControls Linearity FD Tumor Markers II

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Liquichek Cardiac Markers Plus Control LT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    VALIDATE Anemia Calibration Verification/ Linearity Test Kit

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

    Other Clearances by Columbia Diagnostics, Inc.

    K Number Device Name
    K935819 QUALITY CONTROL MATERIAL (ASSAYED)