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

    DU PONT DIMENSION PSEUDOCHOLINESTERASE METHOD

    K Number: K883890 · Decision Nov 29, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    25
    Applicant Total
    253
    Review Days
    76

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    Basic Information

    Device Name
    DU PONT DIMENSION PSEUDOCHOLINESTERASE METHOD
    K Number
    K883890
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.3240
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    E.I. Dupont DE Nemours & Co., Inc.
    Date Received
    September 14, 1988
    Decision Date
    November 29, 1988
    Product Code
    DIH
    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
    DIH Colorimetry, Cholinesterase

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    K951441 DUPONT ACA DIGOXIN (DGN A) METHOD
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    K950134 URINE COCAINE METABOLITE SCREEN FLEX(TM) REAGENT CATRIDGE
    Search all 253 clearances from E.I. Dupont DE Nemours & Co., Inc. →