BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    DIRECT IRON REAGENT SET

    K Number: K812777 · Decision Oct 19, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    66
    Applicant Total
    26
    Review Days
    14

    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
    DIRECT IRON REAGENT SET
    K Number
    K812777
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1410
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    The Dow Chemical Co.
    Date Received
    October 5, 1981
    Decision Date
    October 19, 1981
    Product Code
    JIY
    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
    JIY Photometric Method, Iron (Non-Heme)

    Similar 510(k) Clearances

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

    DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SENTINEL IRON LIQUID

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    VITALAB IRON REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    IRON-PC-SL ASSAY MODEL # 151-10, 151-26

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry
    View all

    Other Clearances by The Dow Chemical Co.

    K Number Device Name
    K823474 ENZYMATIC GLUCOSE DETERMINATION
    K822154 UREA NITROGEN (ENZYMATIC) DETERMINATION
    K821536 DOWFLOW ALT-UV DETERMINATION
    K821315 DOWFLOW ENZYMATIC TRIGLYCERIDES DETERM
    K820675 BILIRUBIN(TOTAL) DETERMINATION CTMS
    K820714 DOW BILIRUBIN(DIRECT) DETERMINATION
    K811806 QUICK-CHEM COLORIMETER
    K810861 CREATINE KINASE MB ISOENZYME IMMUNO UV
    K810727 AST-UV (PLP-ACTIVATED) DETERMINATION
    K801501 UV URIC ACID STANDARDS
    Search all 26 clearances from The Dow Chemical Co. →