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

    IMMULITE(TM) HCG

    K Number: K911796 · Decision Jun 20, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    71
    Applicant Total
    10
    Review Days
    59

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    Basic Information

    Device Name
    IMMULITE(TM) HCG
    K Number
    K911796
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Cirrus Diagnostics, Inc.
    Date Received
    April 22, 1991
    Decision Date
    June 20, 1991
    Product Code
    DHA
    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
    DHA System, Test, Human Chorionic Gonadotropin

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    Other Clearances by Cirrus Diagnostics, Inc.

    K Number Device Name
    K921704 IMMULITE(R) FSH
    K920411 IMMULITE HLH
    K914833 IMMULITE DIGOXIN
    K910677 IMMULITE(TM) T-UPTAKE
    K910261 IMMULITE(TM) TOTAL T4
    K905648 CRP LIPID REAGENT TEST PACK
    K905214 IMMULITE (TM) TOTAL T3
    K905769 IMMULITE HS-TSH
    K905215 IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZER