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

    COBAS IMMUNOASSAY FOR THEOPHYLLINE & CAL

    K Number: K843826 · Decision Feb 1, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    12
    Applicant Total
    296
    Review Days
    126

    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
    COBAS IMMUNOASSAY FOR THEOPHYLLINE & CAL
    K Number
    K843826
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3880
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Roche Diagnostic Systems, Inc.
    Date Received
    September 28, 1984
    Decision Date
    February 1, 1985
    Product Code
    LGS
    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
    LGS Fluorescence Polarization Immunoassay, Theophylline

    Similar 510(k) Clearances

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

    ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    INNOFLUOR THEOPHYLLINE ASSAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    AXSYM THEOPHYLLINE II

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    QMS THEOPHYLLINE CS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    TDX/TDXFLX & TDXFLX THEOPHYLLINE MONOCLONAL II

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

    Other Clearances by Roche Diagnostic Systems, Inc.

    K Number Device Name
    K983698 MODIFICATION TO ABUSCREEN ONLINE BARBITURATES
    K983702 MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES
    K983704 MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE
    K983556 ABUSCREEN ONLINE BENZ 300 CALIBRATORS
    K983555 ABUSCREEN ONLINE BENZ 200 CALIBRATORS
    K983697 MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE
    K983700 MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE
    K983701 MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS
    K983699 MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES
    K983703 MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE
    Search all 296 clearances from Roche Diagnostic Systems, Inc. →