BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Cardiac STATus CK-MB/Myoglob/Trop I

    Reg #: 2246703 · FEI: 2246703 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    PRINCETON BIOMEDITECH CORP.
    Registration Number
    2246703
    FEI Number
    2246703
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4242 U.S. Hwy. 1
    City
    Monmouth Jct
    State
    NJ
    ZIP
    08852
    Country
    US

    Regulatory Submissions

    510(k) Number
    K981882

    Owner / Operator

    Firm Name
    PRINCETON BIOMEDITECH CORP.
    Operator Number
    2246703
    Address
    4242 U.S. HIGHWAY 1, --
    City
    Monmouth Junction
    State
    NJ
    Postal Code
    08852
    Country
    US

    Products

    Device Name Product Code
    Immunoassay Method, Troponin Subunit MMI
    Myoglobin, Fitc, Antigen, Antiserum, Control DEA

    Proprietary Names

    Cardiac STATus CK-MB/Myoglob/Trop I LifeSign MI CK-MB/Myoglobin/Trop I Clarity

    Establishment Types

    Manufacture Medical Device