Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1054657

FEI Number

1000110807

Entity Name

Corning Incorporated Discovery Labware

City/State/Country

Durham, NC, US

Establishment Address

1 BECTON CIR, Durham, NC 27712, 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

Expiration Date (Year)

2026

510(k) Number

K991249

PMA Number

N/A

All Registered Proprietary Names

Falcon IVF Dishes and Plates Falcon In Vitro Fertilization (IVF) Plasticware Corning Spinner Flasks and accessories, various styles and sizes Tissue Culture Dish and BioAssay Dish Custom Transwell Permeable Supports > 100 cm2; PureCoat Cell Culture Plates and Dishes, various Styles and Sizes Primaria flasks greater than 100 square cm surface area. PureCoat Flasks various sizes. Falcon, Costar and Corning CELLBIND cell culture flasks greater than 100 square cm surface area Synthemax Flasks sizes greater than 100 square cm surface area Falcon MultiFlasks, various styles greater than 100 square cm surface area Corning Erlenmeyer Flasks, various sizes; Corning PureCoat rLaminin-521 Cultureware; various sizes HYPERFlasks and HYPERStack vessels and accessories; various styles and sizes CellCube Systems and accessories, various styles and sizes CellSTACK Culture Chambers and accesories, various styles and sizes PureCoat Flasks various sizes Corning and Custom roller bottles and accessories Corning CellBIND roller bottles and accessories; Corning Easy Grip Storage Bottle and accessories Falcon IVF Dishes and Plates Falcon In Vitro Fertilization (IVF) Plasticware Falcon In Vitro Fertilization 4 Well Dish Falcon IVF Plates and Dishes Falcon In Vitro Fertilization (IVF) Plasticware

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQK	Labware, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6160	2012-11-12
KJD	Spinner, Flask	Hematology	Class 1	864.2240	2013-10-28
KIZ	Dish, Tissue Culture	Hematology	Class 1	864.2240	2008-02-11
KJA	Flask, Tissue Culture	Hematology	Class 1	864.2240	2002-02-15
KJC	Bottle, Roller, Tissue Culture	Hematology	Class 1	864.2240	2012-11-12
MQK	Labware, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6160	2012-11-12
PUD	Labware, Assisted Reproduction, Exempt	Obstetrics/Gynecology	Class 2	884.6160	2019-10-28
MQK	Labware, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6160	2012-11-12

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
3011777678	CORNING INCORPORATED	Tewksbury, MA, US
1218905	CORNING-KENNEBUNK	KENNEBUNK, ME, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1054657. Last updated year: 2026. Please use registration number 1054657 when referencing this establishment in official correspondence.