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

    EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641

    K Number: K881116 · Decision Jun 20, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    16
    Applicant Total
    14
    Review Days
    97

    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
    EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641
    K Number
    K881116
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3555
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Diagnostic Systems
    Date Received
    March 15, 1988
    Decision Date
    June 20, 1988
    Product Code
    KLR
    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
    KLR Enzyme Immunoassay, Lidocaine

    Similar 510(k) Clearances

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

    QMS LIDOCAINE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRATOR II, MODELS DF113. DC49D

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ROCHE ONLINE TDM LIDOCAINE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    LIDOCAINE EIA ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    COBAS REAGENT FOR LIDOCAINE & CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    STRATUS LIDOCAINE FLUOROMETRIC ENZYME

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

    Other Clearances by Diagnostic Systems

    K Number Device Name
    K905146 OLYMPUS URINE PH
    K893691 EMDS CREATINE KINASE ITEM NIMBER 65411
    K893692 EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405
    K893966 HDL PRECIPITATING REAGENT
    K884993 VISUAL BLOOD GLUCOSE TEST SYSTEM
    K880787 EASY-TEST LACTIC ACID (LA)
    K862403 EMDS ANTIEPILEPTIC DRUG CALIBRATORS ITEM #67630/95
    K854784 ABSORBANCE (ABS) TEST PAK
    K853699 EASY ANALYZER & EASY-TEST REAGENT
    K853532 ALCOHOL CALIBRATORS
    Search all 14 clearances from Diagnostic Systems →