BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇹 Italy

    SENTINEL UIBC LIQUID

    K Number: K051111 · Decision Nov 17, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    7
    Applicant Total
    10
    Review Days
    199

    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
    SENTINEL UIBC LIQUID
    K Number
    K051111
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1415
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sentinel Ch. Srl
    Date Received
    May 2, 2005
    Decision Date
    November 17, 2005
    Product Code
    JQF
    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
    JQF Bathophenanthroline, Iron Binding Capacity

    Similar 510(k) Clearances

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

    WAKO L-TYPE UIBC, WAKO UIBC CALIBRATOR

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    WAKO(TM) UIBC

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    TRANSFERMETER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    TOTAL IRON BINDING CAPACITY TEST

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    J & S IRON SATURATING REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    IRON & TICB

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

    Other Clearances by Sentinel Ch. Srl

    K Number Device Name
    K070971 MODIFICATION TO SENTINEL CLIN CHEM CAL
    K051447 SENTINEL PANCREATIC AMYLASE
    K051114 SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY
    K051452 SENTINEL CLIN CHEM CAL
    K051456 SENTINEL CERULOPLASMIN
    K051115 SENTINEL IRON LIQUID
    K050836 CRP DIAGNOSTIC ASSAY
    K051457 SENTINEL PLASMAPROTEINS CAL 3X
    K051444 SENTINEL CHOLINESTERASE LIQUID