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

    WORTHINGTON BUN

    K Number: K770470 · Decision Jun 2, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    20
    Applicant Total
    13
    Review Days
    84

    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
    WORTHINGTON BUN
    K Number
    K770470
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1770
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Worthington Biochemical Corp.
    Date Received
    March 10, 1977
    Decision Date
    June 2, 1977
    Product Code
    CDW
    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
    CDW Diacetyl-Monoxime, Urea Nitrogen

    Similar 510(k) Clearances

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

    BLOOD UREA NITROGEN

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    FLOW-PAC UREA NITROGEN REAGENT SET 2214, 2814

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AMRESCO FLOW PAC UREA NITROGEN REAGENTS #1346

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TWIN BUN/GLUCOSE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    UREA NITROGEN REAGENT SET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    UREA

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

    Other Clearances by Worthington Biochemical Corp.

    K Number Device Name
    K780389 HDL REAGENT SET FOR LIPOPROTEINS
    K780096 LDH ISOENZYME CONTROL SERUM
    K772356 LDH ISOENZYME COLUMN REAGENT SET
    K772025 URIC ACID STD. FOR QUANT. URIC ACID
    K771001 STATZYME GLUCOSE
    K771143 INORGANIC PHOSPHORUS STANDARDS
    K770831 STATZYME URIC ACID REAGENT
    K770277 CHOLESTEROL STANDARDS
    K761263 CHOLESTEROL AUTOMATED REAGENT
    K761262 TRIGLYCERIDES (LIPASE) REAGENT SET
    Search all 13 clearances from Worthington Biochemical Corp. →