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

    SYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN CALIBRATOR

    K Number: K013076 · Decision Dec 12, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    30
    Applicant Total
    270
    Review Days
    89

    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
    SYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN CALIBRATOR
    K Number
    K013076
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3950
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beckman Coulter, Inc.
    Date Received
    September 14, 2001
    Decision Date
    December 12, 2001
    Product Code
    LEH
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LEH Radioimmunoassay, Vancomycin

    Similar 510(k) Clearances

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

    Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ONLINE TDM Vancomycin Gen.3

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ARCHITECT IVANCOMYCIN

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    IMMULITE 2000, IMMULITE 2500 VANCOMYCIN

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

    Other Clearances by Beckman Coulter, Inc.

    K Number Device Name
    K252169 Access BNP II
    K254059 Access anti-HBc IgM
    K253687 Access anti-HBc Total
    K251995 Access anti-HAV IgM
    K250588 Access Rubella IgG
    K252580 iQ200 Series
    K243846 Access anti-HAV
    K243804 MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan)
    K250036 MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)
    K243483 Access hsTnI
    Search all 270 clearances from Beckman Coulter, Inc. →