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

    GEMSTAR IPA THEOPHYLLINE TEST KIT

    K Number: K853372 · Decision Sep 4, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    70
    Applicant Total
    41
    Review Days
    23

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    Basic Information

    Device Name
    GEMSTAR IPA THEOPHYLLINE TEST KIT
    K Number
    K853372
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3880
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Electro-Nucleonics Laboratories, Inc.
    Date Received
    August 12, 1985
    Decision Date
    September 4, 1985
    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

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    Other Clearances by Electro-Nucleonics Laboratories, Inc.

    K Number Device Name
    K873925 VIRGO(TM) MEASLES IGG ELISA
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    K873358 GEMENI URIC ACID U.V.
    K873088 VIRGO(TM) RUBELLA IGG ELISA
    K871905 TOXOPLASMA GONDII IGG ELISA
    K870928 CHOLESTEROL (TOTAL) ANALYSIS PRODUCTS
    K863874 LIPASE HYDROLYSIS/GLYCEROL KINASE, TRIGLYCERIDES
    K862640 AMYLASE LTS
    K853373 DELTA TROL I & II
    Search all 41 clearances from Electro-Nucleonics Laboratories, Inc. →