BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Contract Manufactured Collection Device with Ahlstrom 226 filter paper.

    Reg #: 3007145015 · FEI: 3007145015 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Revvity Health Sciences, Inc.
    Registration Number
    3007145015
    FEI Number
    3007145015
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    17 P&N Drive
    City
    Greenville
    State
    SC
    ZIP
    29611
    Country
    US

    Regulatory Submissions

    510(k) Number
    K121864

    Owner / Operator

    Firm Name
    Revvity, Inc.
    Operator Number
    9912035
    Address
    77 4th Avenue
    City
    Waltham
    State
    MA
    Postal Code
    02451
    Country
    US

    Products

    Device Name Product Code
    Newborn Screening Specimen Collection Paper PJC

    Proprietary Names

    Contract Manufactured Collection Device with Ahlstrom 226 filter paper. Revvity 226 Sample Collection Device

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device