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

    ROCHE ONLINE THEOPHYLLINE

    K Number: K020740 · Decision Apr 16, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    70
    Applicant Total
    264
    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
    ROCHE ONLINE THEOPHYLLINE
    K Number
    K020740
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3880
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roche Diagnostics Corp.
    Date Received
    March 6, 2002
    Decision Date
    April 16, 2002
    Product Code
    KLS
    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
    KLS Enzyme Immunoassay, Theophylline

    Similar 510(k) Clearances

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

    VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND III

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    EMIT CAFFEINE ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    RANDOX THEOPHYLLINE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89

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

    Other Clearances by Roche Diagnostics Corp.

    K Number Device Name
    K130138 SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM
    K101365 ELECSYS CA 19-9 CALCHECK 5
    K100853 COBAS 8000 MODULAR SERIES ANALYZER
    K101196 ACCU-CHEK ULTRFLEX INFUSION SET
    K093664 AMPHETAMINES II ASSAY
    K101075 ELECSYS INSULIN CALCHECK 5
    K093421 ELECSYS TESTOSTERONE II IMMUNOASSAY
    K092848 ELECSYS TROPONIN T CALCHECK 5
    K092940 COAGUCHEK XS PLUS PST SYSTEM
    K093700 ELECSYS HCG STAT CALCHECK 5
    Search all 264 clearances from Roche Diagnostics Corp. →