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

    ANALYZER, SERUM IRON & TOTAL IRON BINDIN

    K Number: K781009 · Decision Jul 27, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    38

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    Basic Information

    Device Name
    ANALYZER, SERUM IRON & TOTAL IRON BINDIN
    K Number
    K781009
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1275
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Environmental Sciences Assoc., Inc.
    Date Received
    June 19, 1978
    Decision Date
    July 27, 1978
    Product Code
    JMD
    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
    JMD Radioimmunoassay, Total Estrogens, Nonpregnancy

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (JMD), ordered by most recent decision date.

    TOTAL ESTROGENS KIT BY RIA

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry
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    Other Clearances by Environmental Sciences Assoc., Inc.

    K Number Device Name
    K801439 MODEL 5100 ELECTROCHEMICAL DETECTOR