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

    APSARA CLINICAL DIAG. & INFO. SYS

    K Number: K823386 · Decision Feb 9, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    174
    Registration Numbers
    174
    Same Product Code
    207
    Applicant Total
    5
    Review Days
    86

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    Basic Information

    Device Name
    APSARA CLINICAL DIAG. & INFO. SYS
    K Number
    K823386
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2160
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Datachem, Inc.
    Date Received
    November 15, 1982
    Decision Date
    February 9, 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 Datachem, Inc.

    K Number Device Name
    K900788 MODIFIED APSARA CLINICAL DIAGNOSTIC ANALYZER
    K834534 APSARA ANALYZER
    K813161 FLO TEM II (BLOOD/FLUID WARMER
    K803249 FLUID WARMER