BEUDAMED
    FDA Registration Active 🇺🇸 United States

    R723025 Amies Clear Gel Wire Shaft PK 50

    Reg #: 1924669 · FEI: 1924669 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    REMEL, INC.
    Registration Number
    1924669
    FEI Number
    1924669
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    12076 Santa Fe Trail Dr
    City
    LENEXA
    State
    KS
    ZIP
    66215
    Country
    US

    Regulatory Submissions

    510(k) Number
    K960997

    Owner / Operator

    Firm Name
    Thermo Fisher Scientific
    Operator Number
    2517925
    Address
    168 Third Avenue, --
    City
    Waltham
    State
    MA
    Postal Code
    02451
    Country
    US

    Products

    Device Name Product Code
    Device, Specimen Collection LIO

    Proprietary Names

    R723025 Amies Clear Gel Wire Shaft PK 50 R723010 Amies Clear Gel Dual Swab PK 500 R723000 Amies Clear Gel Single Swab PK 500 R723040 Amies Charcoal Gel Single Swab PK 500 R723015 Amies Clear Gel Dual Swab PK 50 R723095 Liquid Amies Dual Swab PK 50 R723020 Amies Clear Gel Wire Shaft Swab PK 100 R723045 Amies Charcoal Gel Single Swab PK 50

    Establishment Types

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