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

    GAMBRO DQM 200

    K Number: K990039 · Decision Jan 27, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    5
    Applicant Total
    13
    Review Days
    386

    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
    GAMBRO DQM 200
    K Number
    K990039
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1770
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gambro Healthcare
    Date Received
    January 6, 1999
    Decision Date
    January 27, 2000
    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.

    HICHEM BUN REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SIGMA DIAGNOSTICS BUN REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SIGMA 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 Gambro Healthcare

    K Number Device Name
    K994390 GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER
    K982413 COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERS
    K982414 GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS
    K980386 HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100 KITS B22 (B22,B22/B, & B22/0)
    K982760 COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET
    K982818 HOSPAL TIPSTOP
    K974899 GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO H
    K981681 PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)
    K981085 GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM
    K970253 COBE CENTRYSYSTEM 3 DIALYSIS CONTROL UNIT/COBE CARTRIDGE BLOOD TUBING SET
    Search all 13 clearances from Gambro Healthcare →