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

    S-UREA-N, IN VITRO DIAG FOR BUN

    K Number: K761152 · Decision Dec 9, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    15
    Applicant Total
    21
    Review Days
    10

    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
    S-UREA-N, IN VITRO DIAG FOR BUN
    K Number
    K761152
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1770
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Advanced Biomedical Methods, Inc.
    Date Received
    November 29, 1976
    Decision Date
    December 9, 1976
    Product Code
    CDL
    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
    CDL Berthelot Indophenol, Urea Nitrogen

    Similar 510(k) Clearances

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

    RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #2010

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    COLORIMETRIC BUN REAGENT KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    UREA NITROGEN(BUN), COLORIMETRIC METHOD

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    UREA NITROGEN TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    UREAFAST

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

    Other Clearances by Advanced Biomedical Methods, Inc.

    K Number Device Name
    K945353 CLARIT(TM)
    K880949 SINGLE REAGENT CALCIUM FOR DEMAND ANALYZER
    K864866 RESUBMISSION OF THE KLEERZIT REAGENT
    K852784 ALKALINE PHOSPHATASE
    K852783 SGOT/ALT REAGENT
    K852027 GGTP REAGENT/SERUM IRON/SALICYLATE DEMAND ANALYZER
    K850380 INORGANIC PHOSPHOROUS FOR DEMAND ANALYZER
    K850379 DIRECT BILIRUBIN FOR DEMAND ANALYZER
    K850378 LDH REAGENT FOR DEMAND ANALYZER
    K850381 MAGNESIUM REAGENT FOR DEMAND ANALYZER
    Search all 21 clearances from Advanced Biomedical Methods, Inc. →