Beckman Coulter

FDA Filings

This page includes the latest FDA filings for Beckman Coulter. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Beckman Coulter holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

Jennifer Hadfield

FDA Registration(s)

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
PMN K193124 Beckman Coulter	Unicel DxH 800 Coulter Cellular Analysis System	2020-04-16
PMN K182886 Beckman Coulter	Cytomics FC 500 Series (MPL Or MCL) Flow Cytometer	2019-09-06
PMN K183592 Beckman Coulter	ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer	2019-03-21
PMN K181599 Beckman Coulter	Unicel DxH 800 Cellular Analysis System With Early Sepsis Indicator Application	2019-03-18
PMN K181475 Beckman Coulter	DxH 520 Hematology Instrument	2019-03-01
De Novo DEN160047 Beckman Coulter	ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M	2017-06-29
PMN K162897 BECKMAN COULTER	Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser	2017-06-23

Similar & Related FDA Registered Companies

Beckman Coulter Inc.
Beckman Coulter Biomedical GmbH
Beckman Coulter Ireland Inc.
BECKMAN COULTER CELLULAR
BECKMAN COULTER, INC.1000 Lake Hazeltine Dr.chaska, MN 55318 PMA NumberP090026 Supplement NumberS031 Date Received04/19/2021 Decision Date12/16/2022 Product Code OYA Advisory Committee Immunology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
BECKMAN COULTER, INC.250 South Kraemer Blvd M/sw-110brea, CA 92822 PMA NumberP970038 Supplement NumberS045 Date Received04/19/2021 Decision Date12/16/2022 Product Code MTG Advisory Committee Immunology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
BECKMAN COULTER, INC.250 South Kraemer Blvd M/sw-110brea, CA 92822 PMA NumberP850048 Supplement NumberS058 Date Received02/04/2022 Decision Date03/03/2022 Product Code MTF Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

Related Finance Registrations

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092959361	Stadersand,Federal Republic of Germany -> Norfolk, Virginia	POLITAINER	300 PCS
2020092959361	Stadersand,Federal Republic of Germany -> Norfolk, Virginia	POLITAINER	300 PCS
2020092977831	Stadersand,Federal Republic of Germany -> Norfolk, Virginia	POLITAINER	300 PCS
2020092977831	Stadersand,Federal Republic of Germany -> Norfolk, Virginia	POLITAINER	300 PCS
2020091746017	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	LABORATORY ANALYSIS SYSTEM	58 PCS
2020091746017	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	LABORATORY ANALYSIS SYSTEM	58 PCS
2020091746017	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	LABORATORY ANALYSIS SYSTEM	58 PCS
2020091651422	Xiamen,China (Mainland) -> Los Angeles, California	CABINET HOUSING 22CTNS=1PLT H.S CODE 90279054 THIS SHIPMENT CONTAINS NO WOOD PACKING MATERIALS	22 CTN
2020091560877	Anvers,Belgium -> New York/Newark Area, Newark, New Jersey	METAL PARTSNCM: 760429	3 PCS
2020091560877	Anvers,Belgium -> New York/Newark Area, Newark, New Jersey	METAL PARTSNCM: 760429	3 PCS
2020091560877	Anvers,Belgium -> New York/Newark Area, Newark, New Jersey	METAL PARTSNCM: 760429	3 PCS
2020091556952	Xiamen,China (Mainland) -> Los Angeles, California	CABINET HOUSING 22CTNS=1PLT H.S CODE 90279054 THIS SHIPMENT CONTAINS NO WOOD PACKING MATERIALS	22 CTN
2020091147071	Rotterdam,Netherlands -> Norfolk, Virginia	POLITAINER	300 PCS
2020091147071	Rotterdam,Netherlands -> Norfolk, Virginia	POLITAINER	300 PCS
2020091038415	Rotterdam,Netherlands -> Norfolk, Virginia	POLITAINER	300 PCS
2020091038415	Rotterdam,Netherlands -> Norfolk, Virginia	POLITAINER	300 PCS