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

    EMDS SALICYLATE (SAL) TESTPACKS, ITEM NO. 67694/95

    K Number: K872330 · Decision Jul 9, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    28
    Applicant Total
    288
    Review Days
    22

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    Basic Information

    Device Name
    EMDS SALICYLATE (SAL) TESTPACKS, ITEM NO. 67694/95
    K Number
    K872330
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3830
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Em Diagnostic Systems, Inc.
    Date Received
    June 17, 1987
    Decision Date
    July 9, 1987
    Product Code
    DKJ
    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
    DKJ Colorimetry, Salicylate

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    K935174 TOTAL PROTEIN TEST (TPRO)
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    K935136 CHOLESTEROL (CHOL) TEST ITEM NO. 65410
    K935175 LACTATE DEHYDROGENASE (LD)
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