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

    CANTROL SPINAL FLUID CONTROL

    K Number: K854190 · Decision Nov 25, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    3
    Applicant Total
    9
    Review Days
    41

    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
    CANTROL SPINAL FLUID CONTROL
    K Number
    K854190
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.5860
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Canyon Diagnostics, Inc.
    Date Received
    October 15, 1985
    Decision Date
    November 25, 1985
    Product Code
    DFI
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DFI Total Spinal-Fluid, Antigen, Antiserum, Control

    Similar 510(k) Clearances

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

    RESOLVE-CSF

    FDA 510(k)
    FDA Class 1 ·Immunology

    SOMAS HUMAN SPINAL FLUID CONTROL

    FDA 510(k)
    FDA Class 1 ·Immunology

    FIAX IGG TEST

    FDA 510(k)
    FDA Class 1 ·Immunology
    View all

    Other Clearances by Canyon Diagnostics, Inc.

    K Number Device Name
    K970248 CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEM
    K964640 CANTROL IRON/TIBC CONTROLS, LEVEL 1 AND LEVEL 2 PRODUCT NUMBERS: LEVEL 1: IIBC-91 AND LEVEL 2: IIBC-92
    K882488 CANTROL HDL CHOLESTEROL PRECIPI. REAG. AND TUBES
    K871537 CANTROL HDL CHOLESTROL CONTROLS LEVELS I AND II
    K854931 CANTROL ELECTROPHORESIS CONTROL
    K855006 CANTROL CK/MB CONTROL
    K853603 CANTROL URINE DIPSTICK CONTROL TWO LEVELS
    K852138 WESCOR STAIN PACK FOR MODEL 7100 AEROSPRAY SLIDE S