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

    DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A

    K Number: K060619 · Decision Jul 21, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    85
    Applicant Total
    41
    Review Days
    135

    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
    DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A
    K Number
    K060619
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1160
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Diazyme Laboratories
    Date Received
    March 8, 2006
    Decision Date
    July 21, 2006
    Product Code
    KHS
    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
    KHS Enzymatic, Carbon-Dioxide

    Similar 510(k) Clearances

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

    Carbon Dioxide Reagent Set

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Liquid CO2-2 (LCO2-2)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AU BICARBONATE REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VITROS CHEMISTRY PRODUCTS ECO2 SLIDES

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

    Other Clearances by Diazyme Laboratories

    K Number Device Name
    K172992 Diazyme EZ Vitamin D Assay
    K163418 Diazyme DZ-Lite Total beta-hCG Test System
    K162297 Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set
    K160762 Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set
    K153394 Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme Human Kappa/Lamda Free Light Chain Calibrator, Diazyme Human Kappa/Lamda Free Light Chain Calibrator
    K161646 Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set
    K161721 Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set
    K143470 Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set
    K133803 DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT
    K133083 DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET
    Search all 41 clearances from Diazyme Laboratories →