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

    COLLOID OSMOMETER 4400

    K Number: K834208 · Decision Mar 23, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    11
    Applicant Total
    13
    Review Days
    109

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    Basic Information

    Device Name
    COLLOID OSMOMETER 4400
    K Number
    K834208
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2730
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Wescor, Inc.
    Date Received
    December 5, 1983
    Decision Date
    March 23, 1984
    Product Code
    JJM
    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
    JJM Osmometer For Clinical Use

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    Other Clearances by Wescor, Inc.

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    K881592 WESCOR MODEL 7300 AEROSPRAY GRAM STAINER
    K881512 WESCOR GRAM STAIN PACK FOR MODEL 7300 AEROSPRAY
    K880544 WESCOR STAIN CONCENTRATE FOR MODEL 7100 AEROSPRAY
    K853973 WESCOR MODEL 3700 WEBSTER SWEAT INDUCER
    K834214 WESCOR 5500 VAPOR PRESSURE OSMOMETER
    K840472 SYS MACRODUCT SWEAT COLLECTION SYS 3600
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