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

    QCA HEMOGLOBIN KIT

    K Number: K843695 · Decision Dec 17, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    24
    Applicant Total
    632
    Review Days
    89

    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
    QCA HEMOGLOBIN KIT
    K Number
    K843695
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.8165
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Bd Becton Dickinson Vacutainer Systems Preanalytic
    Date Received
    September 19, 1984
    Decision Date
    December 17, 1984
    Product Code
    KRZ
    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
    KRZ Calibrator For Hemoglobin And Hematocrit Measurement

    Similar 510(k) Clearances

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

    C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C

    FDA 510(k)
    FDA Class 2 ·Hematology

    CDS HEMATOLOGY CALIBRATOR (CDS CAL)

    FDA 510(k)
    FDA Class 2 ·Hematology

    THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS

    FDA 510(k)
    FDA Class 2 ·Hematology

    ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS

    FDA 510(k)
    FDA Class 2 ·Hematology

    CELL-DYN CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Hematology

    RAICHEM TM HEMOGLOBIN CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Hematology
    View all

    Other Clearances by Bd Becton Dickinson Vacutainer Systems Preanalytic

    K Number Device Name
    K003062 BACTEC MGIT 960 SIR KITS
    K003553 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE
    K003461 BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE
    K002938 B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16
    K001364 BD DIRECTIGEN FLU A+B
    K000762 MOXIFLOXACIN, 5 UG, BBL SENSI-DISC
    K000829 GATIFLOXACIN, 5 UG, BBL SENSI-DISC
    K993186 SYNERCID, 15 UG, BBL SENSI-DISC
    K992734 BECTON DICKINSON SYRINGE
    K991551 VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE
    Search all 632 clearances from Bd Becton Dickinson Vacutainer Systems Preanalytic →