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

    LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA

    K Number: K083878 · Decision Jun 25, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    15
    Applicant Total
    10
    Review Days
    543

    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
    LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA
    K Number
    K083878
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.8950
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    R2 Diagnostics, Inc.
    Date Received
    December 29, 2008
    Decision Date
    June 25, 2010
    Product Code
    GIR
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GIR Reagent, Russel Viper Venom

    Similar 510(k) Clearances

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

    REAGENT, RUSSEL VIPER VENOM - LA SCREEN

    FDA 510(k)
    FDA Class 1 ·Hematology

    REAGENT, RUSSEL VIPER VENOM - LA CONFIRM

    FDA 510(k)
    FDA Class 1 ·Hematology

    HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM

    FDA 510(k)
    FDA Class 1 ·Hematology

    STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM

    FDA 510(k)
    FDA Class 1 ·Hematology

    ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119

    FDA 510(k)
    FDA Class 1 ·Hematology

    ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094

    FDA 510(k)
    FDA Class 1 ·Hematology
    View all

    Other Clearances by R2 Diagnostics, Inc.

    K Number Device Name
    K102908 NOFACT IX
    K102851 NOFACT VIII
    K090105 LUPOTEK KCT
    K082631 THROMBO TEK PSE, MODEL 90-480
    K062306 PLASMACON N, PLASMACON L-1, PLASMACON L-2
    K050817 T-TEK
    K042919 FIBROTEK FIB
    K040296 PHOSPHOPLASTIN RL
    K033471 PHOSPHOLIN ES AND CALCIUM CHLORIDE