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

    IMMULITE HLH

    K Number: K920411 · Decision Mar 11, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    142
    Applicant Total
    10
    Review Days
    40

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    Basic Information

    Device Name
    IMMULITE HLH
    K Number
    K920411
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1485
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cirrus Diagnostics, Inc.
    Date Received
    January 31, 1992
    Decision Date
    March 11, 1992
    Product Code
    CEP
    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
    CEP Radioimmunoassay, Luteinizing Hormone

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    Other Clearances by Cirrus Diagnostics, Inc.

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    K905214 IMMULITE (TM) TOTAL T3
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