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

    FERMCOTEST CO2 REAGNET

    K Number: K822117 · Decision Sep 30, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    27
    Applicant Total
    8
    Review Days
    73

    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
    FERMCOTEST CO2 REAGNET
    K Number
    K822117
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1160
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Fermco Biochemics, Inc.
    Date Received
    July 19, 1982
    Decision Date
    September 30, 1982
    Product Code
    JFL
    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
    JFL Ph Rate Measurement, Carbon-Dioxide

    Similar 510(k) Clearances

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

    i-STAT CHEM8+ cartridge with the i-STAT 1 System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GENCHEM CO2 ACID REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SIGMA DIAGNOSTICS CO2 ACID REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SIGMA DIAGNOSTICS CO2ALKALINE BUFFER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SIGMA DIAGNOSTICS ELECTROLYTE BUFFER

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

    Other Clearances by Fermco Biochemics, Inc.

    K Number Device Name
    K843832 TRIGLYCERIDES REAGENT SYSTEM
    K823106 RERMCO TEST CHLORIDE REAGENT
    K822118 FERMCOTEST CREATININE TEST REAGENT
    K810567 GERMCO TEST R GLUCOSE TEST KIT
    K791066 GLUCOSE GOD-PAP TRINDER METHOD TEST KIT
    K791018 FERMCOTEST R BUN RATE REAGENT TEST KIT
    K781945 GLUCOSE OXIDASE REAGENT