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

    EASY-TEST (CHE) REAGENT, ITEM NO. 67522/93

    K Number: K860641 · Decision Apr 3, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    5
    Applicant Total
    288
    Review Days
    42

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    Basic Information

    Device Name
    EASY-TEST (CHE) REAGENT, ITEM NO. 67522/93
    K Number
    K860641
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.3240
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Em Diagnostic Systems, Inc.
    Date Received
    February 20, 1986
    Decision Date
    April 3, 1986
    Product Code
    DLI
    Advisory Committee
    Clinical Toxicology
    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
    DLI Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase

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