Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021492213

FEI Number

3021492213

Entity Name

RR DONNELLEY

City/State/Country

Houston, TX, US

Establishment Address

6315 West By Northwest Blvd, Houston, TX 77040, US

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

RR Donnelley (Owner Number: 10088146)

Owner / Operator Contact Address

6315 West By Northwest Blvd, Houston, TX 77040, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sample Collection Kit, Stool

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2023-06-01

Official Correspondent

Lee Rush

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

RR Donnelley

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3011213695	AHLSTROM GERMANY GMBH	Barenstein Saxony, DE
3014787189	NOVOGENIA GMBH	Eugendorf Salzburg, AT
3007261225	GENE BY GENE	Houston, TX, US
3030125016	MED AUXIL ANALYSIS AIDS E.K.	Seesen Lower Saxony, DE
3017067307	DYAD ENTERPRISE LLC	King of Prussia, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021492213. Last updated year: 2026. Please use registration number 3021492213 when referencing this establishment in official correspondence.