BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Tosoh ST AIA-PACK HbA1c

    Reg #: 3005529799 · FEI: 3005529799 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    TOSOH BIOSCIENCE, INC.
    Registration Number
    3005529799
    FEI Number
    3005529799
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3600 Gantz Rd
    City
    Grove City
    State
    OH
    ZIP
    43123
    Country
    US

    Regulatory Submissions

    510(k) Number
    K100304

    Owner / Operator

    Firm Name
    TOSOH BIOSCIENCE
    Operator Number
    8031673
    Address
    3600 Gantz Road
    City
    Grove City
    State
    OH
    Postal Code
    43123
    Country
    US
    Correspondent
    Joshua D Levin

    Products

    Device Name Product Code
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Assay, Glycosylated Hemoglobin LCP
    Calibrator, Secondary JIT

    Proprietary Names

    Tosoh ST AIA-PACK HbA1c

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device