BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇪 Ireland

    RANDOX PHENYTOIN

    K Number: K011393 · Decision Dec 4, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    43
    Applicant Total
    116
    Review Days
    211

    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
    RANDOX PHENYTOIN
    K Number
    K011393
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3350
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Randox Laboratories, Ltd.
    Date Received
    May 7, 2001
    Decision Date
    December 4, 2001
    Product Code
    DIP
    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
    DIP Enzyme Immunoassay, Diphenylhydantoin

    Similar 510(k) Clearances

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

    ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ROCHE ONLINE TDM PHENYTOIN

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2, L2KPN6

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ABBOT AEROSET PHENYTOIN ASSAY & ABBOT AEROSET PHENYTOIN CALIBRATORS

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

    Other Clearances by Randox Laboratories, Ltd.

    K Number Device Name
    DEN240035 ConcizuTrace™ ELISA
    K230890 ISE Electrodes
    K182042 Randox Calcium (Ca)
    K162200 Randox RX Daytona Plus Magnesium (MG)
    K152085 Liquid CO2-2 (LCO2-2)
    K153435 Direct HDL Cholesterol (HDL)
    K150654 Cholesterol
    K131554 RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT
    K123977 RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR
    K132156 RANDOX CSF CONTROLS LEVELS 2 AND 3
    Search all 116 clearances from Randox Laboratories, Ltd. →