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

    ISO-DATA CENTRIFUGES 1-A, 101, 2D, ETC.

    K Number: K843434 · Decision Oct 5, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    37
    Applicant Total
    7
    Review Days
    31

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    Basic Information

    Device Name
    ISO-DATA CENTRIFUGES 1-A, 101, 2D, ETC.
    K Number
    K843434
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2050
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Iso-Data, Inc.
    Date Received
    September 4, 1984
    Decision Date
    October 5, 1984
    Product Code
    JQC
    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
    JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use

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    Other Clearances by Iso-Data, Inc.

    K Number Device Name
    K872429 ISO-DATA 100 SERIES GAMMA COUNTER
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    K843365 ISO-DATA IMMUNOASSAY NETWORK SYSTEM
    K810631 DPM CALCULATOR
    K780813 IDI GDR DATA REDUCTION SYSTEM
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