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

    SIGMA BUN REAGENT

    K Number: K933679 · Decision Dec 17, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    5
    Applicant Total
    231
    Review Days
    142

    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
    SIGMA BUN REAGENT
    K Number
    K933679
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1770
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sigma Chemical Co.
    Date Received
    July 28, 1993
    Decision Date
    December 17, 1993
    Product Code
    LFP
    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
    LFP Conductivity Rate, Urea Nitrogen

    Similar 510(k) Clearances

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

    GAMBRO DQM 200

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HICHEM BUN REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SIGMA DIAGNOSTICS BUN REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BUN REAGENT KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    LIQUILYME BUN REAGENT

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

    Other Clearances by Sigma Chemical Co.

    K Number Device Name
    K933694 SIGMA GLUCOSE REAGENT
    K933678 SIGMA CALCIUM REAGENT
    K933696 SIGMA ELECTROLYTE REFERENCE REAGENT
    K933691 SIGMA CO2 ALKALINE BUFFER REAGENT
    K933703 SIGMA WASH CONCENTRATE SOLUTION
    K933692 SIGMA CO2 ACID REAGENT
    K933695 SIGMA ELECTROLYTE BUFFER
    K933697 SIGMA CRE REAGENT
    K933693 SIGMA CX-3 CALIBRATION STANDARD LEVEL 2
    K933702 SIGMA CX-3 CALIBRATION STANDARD LEVEL 1
    Search all 231 clearances from Sigma Chemical Co. →