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

    BEHRING POLAROID OPUS THEOPHYLLINE

    K Number: K885044 · Decision Dec 29, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    70
    Applicant Total
    35
    Review Days
    24

    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
    BEHRING POLAROID OPUS THEOPHYLLINE
    K Number
    K885044
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3880
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Pb Diagnostic Systems, Inc.
    Date Received
    December 5, 1988
    Decision Date
    December 29, 1988
    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

    ROCHE ONLINE THEOPHYLLINE

    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
    View all

    Other Clearances by Pb Diagnostic Systems, Inc.

    K Number Device Name
    K940507 OPUS FT4 TEST SYSTEM
    K934762 OPUS PROCAINAMIDE TEST SYSTEM
    K933389 OPUS CMV-G
    K934137 OPUS(R) SEROLOGY CONTROLS, MODIFICATION
    K935229 OPUS DIGITOXIN
    K934705 OPUS NAPA
    K933675 OPUS TOTAL CK
    K933066 OPUS ESTRADIOL
    K932279 OPUS(R) TOTAL B-HCG TEST SYSTEM
    K926131 OPUS MAGNUM ANALYZER
    Search all 35 clearances from Pb Diagnostic Systems, Inc. →