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

    AUTOPAK TEST DELIVERY SYSTEM

    K Number: K790907 · Decision Jun 27, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    120
    Applicant Total
    42
    Review Days
    47

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    Basic Information

    Device Name
    AUTOPAK TEST DELIVERY SYSTEM
    K Number
    K790907
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1700
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Micromedic Systems
    Date Received
    May 11, 1979
    Decision Date
    June 27, 1979
    Product Code
    CDX
    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
    CDX Radioimmunoassay, Total Thyroxine

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    Other Clearances by Micromedic Systems

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    K870245 AUTOPAK TSH MONOCLONAL IRMA KIT
    K862206 TAURUS (TM) AUTOMATIC LIQUID SCINTILLATION COUNTER
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    K861320 MMS T4 RIA KIT
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