Beckman Coulter K K

FDA Filings

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

FDA Registration(s)

• Registration Number: 3008244372
• FEI Number: 3008244372
• Name: Beckman Coulter K. K.
• Owner & Operator: BECKMAN COULTER, INC.
• Contact Address: 250 S. Kraemer Blvd --; Brea CA 92821 US
• Official Correspondent:
  • David G Davis
  • x-469-2368180-x
• US Agent:
  • Dave G. Davis
  • 469 2368180
  • dgdavis@beckman.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 454-32 Higashino, Nagaizumi-Cho ; Sunto-Gun Sizuoka, 411-0931 JP
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
PMN K161837 | NQD Beckman Coulter K. K. [BECKMAN COULTER, INC.]	B86446 DxC 700 AU for Direct Track Sampling with ISE	2016-12-20
PMN K161837 | NQD Beckman Coulter K. K. [BECKMAN COULTER, INC.]	B86445 DxC 700 AU for Direct Track Sampling	2016-12-20
PMN K161837 | NQD Beckman Coulter K. K. [BECKMAN COULTER, INC.]	B86444 DxC 700 AU with ISE	2016-12-20
PMN K161837 | NQD Beckman Coulter K. K. [BECKMAN COULTER, INC.]	B86443 DxC 700 AU	2016-12-20
PMN K161837 | JJE Beckman Coulter K. K. [BECKMAN COULTER, INC.]	B86446 DxC 700 AU for Direct Track Sampling with ISE	2016-12-20
PMN K161837 | JJE Beckman Coulter K. K. [BECKMAN COULTER, INC.]	B86445 DxC 700 AU for Direct Track Sampling	2016-12-20
PMN K161837 | JJE Beckman Coulter K. K. [BECKMAN COULTER, INC.]	B86444 DxC 700 AU with ISE	2016-12-20
PMN K161837 | JJE Beckman Coulter K. K. [BECKMAN COULTER, INC.]	B86443 DxC 700 AU	2016-12-20
PMN K161837 | JGS Beckman Coulter K. K. [BECKMAN COULTER, INC.]	B86446 DxC 700 AU for Direct Track Sampling with ISE	2016-12-20
PMN K161837 | JGS Beckman Coulter K. K. [BECKMAN COULTER, INC.]	B86445 DxC 700 AU for Direct Track Sampling	2016-12-20
PMN K161837 | JGS Beckman Coulter K. K. [BECKMAN COULTER, INC.]	B86444 DxC 700 AU with ISE	2016-12-20
PMN K161837 | JGS Beckman Coulter K. K. [BECKMAN COULTER, INC.]	B86443 DxC 700 AU	2016-12-20
PMN K161837 | CGZ Beckman Coulter K. K. [BECKMAN COULTER, INC.]	B86446 DxC 700 AU for Direct Track Sampling with ISE	2016-12-20
PMN K161837 | CGZ Beckman Coulter K. K. [BECKMAN COULTER, INC.]	B86445 DxC 700 AU for Direct Track Sampling	2016-12-20
PMN K161837 | CGZ Beckman Coulter K. K. [BECKMAN COULTER, INC.]	B86444 DxC 700 AU with ISE	2016-12-20
PMN K161837 | CGZ Beckman Coulter K. K. [BECKMAN COULTER, INC.]	B86443 DxC 700 AU	2016-12-20
PMN K161837 | CFR Beckman Coulter K. K. [BECKMAN COULTER, INC.]	B86446 DxC 700 AU for Direct Track Sampling with ISE	2016-12-20
PMN K161837 | CFR Beckman Coulter K. K. [BECKMAN COULTER, INC.]	B86445 DxC 700 AU for Direct Track Sampling	2016-12-20
PMN K161837 | CFR Beckman Coulter K. K. [BECKMAN COULTER, INC.]	B86444 DxC 700 AU with ISE	2016-12-20
PMN K161837 | CFR Beckman Coulter K. K. [BECKMAN COULTER, INC.]	B86443 DxC 700 AU	2016-12-20
PMN K161837 | CEM Beckman Coulter K. K. [BECKMAN COULTER, INC.]	B86446 DxC 700 AU for Direct Track Sampling with ISE	2016-12-20
PMN K161837 | CEM Beckman Coulter K. K. [BECKMAN COULTER, INC.]	B86445 DxC 700 AU for Direct Track Sampling	2016-12-20
PMN K161837 | CEM Beckman Coulter K. K. [BECKMAN COULTER, INC.]	B86444 DxC 700 AU with ISE	2016-12-20
PMN K161837 | CEM Beckman Coulter K. K. [BECKMAN COULTER, INC.]	B86443 DxC 700 AU	2016-12-20
PMN K112412 | JJE Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU5800	2011-12-29
PMN K112412 | JGJ Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU5800	2011-12-29
PMN K112412 | CFR Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU5800	2011-12-29
PMN K112412 | CEM Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU5800	2011-12-29
PMN K961274 | JJE Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU680	2010-07-14
PMN BK060024 | KSZ Beckman Coulter K. K. [BECKMAN COULTER, INC.]	PK7300	2009-09-02
PMN BK060024 | KSZ Beckman Coulter K. K. [BECKMAN COULTER, INC.]	PK7300 Automated Microplate System	2009-09-02
PMN K981743 | JMO Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | JMO Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | JLB Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | JLB Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | JJE Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | JJE Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | JIY Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | JIY Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | JHN Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | JHN Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | JGS Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | JGS Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | JGJ Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | JGJ Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | JFJ Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | JFJ Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | DOD Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | DOD Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | DHR Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | DHR Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | DGI Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | DGI Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | DEF Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | DEF Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | DCN Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | DCN Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | CZW Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | CZW Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | CKB Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | CKB Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | CJE Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | CJE Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | CIX Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | CIX Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | CIT Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | CIT Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | CIG Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | CIG Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | CIC Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | CIC Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | CHJ Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | CHJ Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | CHH Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | CHH Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | CGX Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | CGX Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | CGS Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | CGS Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | CFR Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | CFR Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | CFQ Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | CFQ Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | CEO Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | CEO Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | CDQ Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | CDQ Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | CDO Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | CDO Beckman Coulter K. K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13

Similar & Related FDA Registered Companies

• 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 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

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S.A.M. Registration

SZ356 [690627757]

BECKMAN COULTER K.K.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092553985	Tokyo ,Japan -> Los Angeles, California	MEDICAL EQUIPMENT	56 CTN
2020092553985	Tokyo ,Japan -> Los Angeles, California	MEDICAL EQUIPMENT	56 CTN
2020091524548	Tokyo ,Japan -> Los Angeles, California	MEDICAL EQUIPMENT	20 PKG
2020091138431	Tokyo ,Japan -> Los Angeles, California	MEDICAL EQUIPMENT	20 PKG
2020091162341	Tokyo ,Japan -> Los Angeles, California	MEDICAL EQUIPMENT	32 PKG
2020091162341	Tokyo ,Japan -> Los Angeles, California	MEDICAL EQUIPMENT	32 PKG
2020090450596	Tokyo ,Japan -> Los Angeles, California	MEDICAL EQUIPMENT	20 PKG
2020090321030	Tokyo ,Japan -> Los Angeles, California	MEDICAL EQUIPMENT	26 CTN
2020082856660	Tokyo ,Japan -> Los Angeles, California	MEDICAL EQUIPMENT	20 PKG
2020082077423	Tokyo ,Japan -> Los Angeles, California	-CLEANING SOLUTION-	36 CTN