CORNING INCORPORATED

FDA Device Registration & Listing · Tewksbury, MA, US · Registration 3011777678

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011777678
FEI Number
3011777678
Entity Name
CORNING INCORPORATED
City/State/Country
Tewksbury, MA, US
Establishment Address
836 North St Bldg 300 Ste 3401, Tewksbury, MA 01876, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Corning Incorporated (Owner Number: 1317452)
Owner / Operator Contact Address
836 North Street, Building 300, Tewksbury, MA 01876, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Corning Disposable Spinner Flasks X-LAB System; X-WASH System and accessories

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KJE Spinner System, Cell Culture Hematology Class 1 864.2240 2011-10-27
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use Clinical Chemistry Class 1 862.2050 2014-12-11

Official Correspondent

Amber Aagaard

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Corning Incorporated
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3006847360 Corning Science Mexico Reynosa Tamaulipas, MX
1316282 CORNING-ONEONTA ONEONTA, NY, US
1218905 CORNING-KENNEBUNK KENNEBUNK, ME, US
1054657 Corning Incorporated Discovery Labware Durham, NC, US

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0002-2008 Beckman Coulter Inc 1
FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013 Biomerieux Inc 1
PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011777678. Last updated year: 2026. Please use registration number 3011777678 when referencing this establishment in official correspondence.
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