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

    UREA NITROGEN TEST

    K Number: K903334 · Decision Sep 7, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    116
    Applicant Total
    288
    Review Days
    44

    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
    UREA NITROGEN TEST
    K Number
    K903334
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1770
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Em Diagnostic Systems, Inc.
    Date Received
    July 25, 1990
    Decision Date
    September 7, 1990
    Product Code
    CDQ
    Advisory Committee
    Clinical Chemistry
    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
    CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen

    Similar 510(k) Clearances

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

    Urea Nitrogen2

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    EASYRA UREA NITROGEN AND CREATININE REAGENTS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    UREA/BUN, SCAL, NORTROL, ABTROL

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry
    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. →