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

    EASY-TEST EMIT(R) AMIKACIN (AMIK) NO. 16645

    K Number: K873426 · Decision Oct 29, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    3
    Applicant Total
    288
    Review Days
    65

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    Basic Information

    Device Name
    EASY-TEST EMIT(R) AMIKACIN (AMIK) NO. 16645
    K Number
    K873426
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3035
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Em Diagnostic Systems, Inc.
    Date Received
    August 25, 1987
    Decision Date
    October 29, 1987
    Product Code
    KLP
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KLP Amikacin Serum Assay

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