BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EasyRA Creatinine Kinase (CK) Reagent

    Reg #: 1220972 · FEI: 1220972 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    MEDICA CORP.
    Registration Number
    1220972
    FEI Number
    1220972
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5 OAK PARK DRIVE
    City
    BEDFORD
    State
    MA
    ZIP
    01730
    Country
    US

    Regulatory Submissions

    510(k) Number
    K123802

    Owner / Operator

    Firm Name
    MEDICA CORP.
    Operator Number
    1220972
    Address
    5 OAK PARK DRIVE, --
    City
    Bedford
    State
    MA
    Postal Code
    01730
    Country
    US
    Correspondent
    Photios E Makris

    Products

    Device Name Product Code
    Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes CGS
    Diazo Colorimetry, Bilirubin CIG

    Proprietary Names

    EasyRA Creatinine Kinase (CK) Reagent EasyRA Total Bilirubin (TBIL) Reagent EasyRA Direct Bilirubin (DBIL) Reagent

    Establishment Types

    Manufacture Medical Device