BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    THERMOMIXER S213-PHOTOANALYZER S263

    K Number: K831649 · Decision Aug 24, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    174
    Registration Numbers
    174
    Same Product Code
    207
    Applicant Total
    10
    Review Days
    93

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    Basic Information

    Device Name
    THERMOMIXER S213-PHOTOANALYZER S263
    K Number
    K831649
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2160
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Texas Intl. Laboratories, Inc.
    Date Received
    May 23, 1983
    Decision Date
    August 24, 1983
    Product Code
    JJE
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

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    Other Clearances by Texas Intl. Laboratories, Inc.

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    K900685 CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER
    K884006 HEMAT 12
    K883177 H 10 OR HEMATIL 10 BLOOD CELL & PLATELET COUNTER
    K853722 PLT-4 PLATELET ANALYZER
    K832886 FLAME PHOTOMETER T281-T282-T283
    K832890 HEMACOMP 7 OR HEMATIL 7