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

    EMDS TM PHENYTOIN (PTN) TESTPACK, ITEM #67676/95

    K Number: K864925 · Decision Jan 7, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    43
    Applicant Total
    288
    Review Days
    22

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    Basic Information

    Device Name
    EMDS TM PHENYTOIN (PTN) TESTPACK, ITEM #67676/95
    K Number
    K864925
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3350
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Em Diagnostic Systems, Inc.
    Date Received
    December 16, 1986
    Decision Date
    January 7, 1987
    Product Code
    DIP
    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
    DIP Enzyme Immunoassay, Diphenylhydantoin

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    Other Clearances by Em Diagnostic Systems, Inc.

    K Number Device Name
    K935181 ASPARTATE AMINOTRANSFERASE (AST) TEST
    K935180 ALANINE AMINOTRANSFERASE (ALT) TEST
    K935178 EMDS PHOSPHOROUS (PHOS) TEST
    K935179 EMDS ALBUMIN (ALB) TEST
    K935174 TOTAL PROTEIN TEST (TPRO)
    K935177 GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST
    K935136 CHOLESTEROL (CHOL) TEST ITEM NO. 65410
    K935175 LACTATE DEHYDROGENASE (LD)
    K935176 IRON TEST
    K935183 EMDS MAGNESIUM (MG) TEST
    Search all 288 clearances from Em Diagnostic Systems, Inc. →