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

    EMDS THEOPHYLLINE TESTPACKS ITEM #67662/95

    K Number: K864041 · Decision Nov 25, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    70
    Applicant Total
    288
    Review Days
    40

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    EMDS THEOPHYLLINE TESTPACKS ITEM #67662/95
    K Number
    K864041
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3880
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Em Diagnostic Systems, Inc.
    Date Received
    October 16, 1986
    Decision Date
    November 25, 1986
    Product Code
    KLS
    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
    KLS Enzyme Immunoassay, Theophylline

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (KLS), ordered by most recent decision date.

    VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND III

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    EMIT CAFFEINE ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ROCHE ONLINE THEOPHYLLINE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    RANDOX THEOPHYLLINE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology
    View all

    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. →