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

    SERIM BLOOD LEAK TEST STRIP

    K Number: K990206 · Decision Apr 21, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    3
    Applicant Total
    27
    Review Days
    90

    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
    SERIM BLOOD LEAK TEST STRIP
    K Number
    K990206
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Serim Research Corp.
    Date Received
    January 21, 1999
    Decision Date
    April 21, 1999
    Product Code
    FJD
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FJD Detector, Leak, Blood

    Similar 510(k) Clearances

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

    E-Z CHEK BLOOD LEAK TEST STRIPS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    STERICHEK BLOOD LEAK REAGENT STRIPS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SERIM BLOOD LEAK TEST STRIP-2

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Serim Research Corp.

    K Number Device Name
    K120652 RAPICIDE OPA-28 TEST STRIP
    K092346 SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 5171
    K083295 SERIM DISINTEK GTA 2.1%, MODEL: 5164
    K082352 SERIM DISINTEK OPA TEST STRIP
    K081370 SERIM DISINTEK OPA TEST STRIP
    K080712 SERIM HISENSE ULTRA 0.1, PART NUMBER 5167
    K052388 SERIM PERACETIC ACID CHEMICAL INDICATOR
    K043031 SERIM DIALYSATE MONITOR TEST STRIP
    K014038 PYLORITEK VP TEST KIT 5140VP
    K012115 SERIM BLOOD LEAK TEST STRIP-2
    Search all 27 clearances from Serim Research Corp. →