Beckman Coulter Mishima K K

FDA Filings

This page includes the latest FDA filings for Beckman Coulter Mishima 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: 9612296
• FEI Number: 3002807663
• Name: Beckman Coulter Mishima 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: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K161837 | NQD Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	B86446 DxC 700 AU for Direct Track Sampling with ISE	2016-12-20
PMN K161837 | NQD Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	B86445 DxC 700 AU for Direct Track Sampling	2016-12-20
PMN K161837 | NQD Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	B86444 DxC 700 AU with ISE	2016-12-20
PMN K161837 | NQD Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	B86443 DxC 700 AU	2016-12-20
PMN K161837 | JJE Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	B86446 DxC 700 AU for Direct Track Sampling with ISE	2016-12-20
PMN K161837 | JJE Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	B86445 DxC 700 AU for Direct Track Sampling	2016-12-20
PMN K161837 | JJE Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	B86444 DxC 700 AU with ISE	2016-12-20
PMN K161837 | JJE Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	B86443 DxC 700 AU	2016-12-20
PMN K161837 | JGS Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	B86446 DxC 700 AU for Direct Track Sampling with ISE	2016-12-20
PMN K161837 | JGS Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	B86445 DxC 700 AU for Direct Track Sampling	2016-12-20
PMN K161837 | JGS Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	B86444 DxC 700 AU with ISE	2016-12-20
PMN K161837 | JGS Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	B86443 DxC 700 AU	2016-12-20
PMN K161837 | CGZ Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	B86446 DxC 700 AU for Direct Track Sampling with ISE	2016-12-20
PMN K161837 | CGZ Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	B86445 DxC 700 AU for Direct Track Sampling	2016-12-20
PMN K161837 | CGZ Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	B86444 DxC 700 AU with ISE	2016-12-20
PMN K161837 | CGZ Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	B86443 DxC 700 AU	2016-12-20
PMN K161837 | CFR Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	B86446 DxC 700 AU for Direct Track Sampling with ISE	2016-12-20
PMN K161837 | CFR Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	B86445 DxC 700 AU for Direct Track Sampling	2016-12-20
PMN K161837 | CFR Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	B86444 DxC 700 AU with ISE	2016-12-20
PMN K161837 | CFR Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	B86443 DxC 700 AU	2016-12-20
PMN K161837 | CEM Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	B86446 DxC 700 AU for Direct Track Sampling with ISE	2016-12-20
PMN K161837 | CEM Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	B86445 DxC 700 AU for Direct Track Sampling	2016-12-20
PMN K161837 | CEM Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	B86444 DxC 700 AU with ISE	2016-12-20
PMN K161837 | CEM Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	B86443 DxC 700 AU	2016-12-20
PMN K112412 | JJE Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU5800	2011-12-29
PMN K112412 | JGJ Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU5800	2011-12-29
PMN K112412 | CFR Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU5800	2011-12-29
PMN K112412 | CEM Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU5800	2011-12-29
PMN K961274 | JJE Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU680	2010-07-14
PMN BK060024 | KSZ Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	PK7300	2009-09-02
PMN BK060024 | KSZ Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	PK7300 Automated Microplate System	2009-09-02
PMN K981743 | JMO Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | JMO Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | JLB Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | JLB Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | JJE Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | JJE Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | JIY Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | JIY Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | JHN Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | JHN Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | JGS Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | JGS Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | JGJ Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | JGJ Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | JFJ Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | JFJ Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | DOD Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | DOD Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | DHR Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | DHR Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | DGI Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | DGI Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | DEF Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | DEF Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | DCN Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | DCN Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | CZW Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | CZW Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | CKB Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | CKB Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | CJE Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | CJE Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | CIX Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | CIX Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | CIT Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | CIT Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | CIG Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | CIG Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | CIC Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | CIC Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | CHJ Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | CHJ Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | CHH Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | CHH Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | CGX Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | CGX Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | CGS Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | CGS Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | CFR Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | CFR Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | CFQ Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | CFQ Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | CEO Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | CEO Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | CDQ Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | CDQ Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K981743 | CDO Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU480	2009-08-13
PMN K981743 | CDO Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AU Beckman Coulter Chemistry Analyzers	2009-08-13
PMN K921718 | JGS Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	ISE unit for AU analyzers	2009-08-13
PMN K921718 | JGS Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AUH1018 ISE Na+/K+ Selectivity Check Solution	2009-08-13
PMN K921718 | JGS Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AUH1017 ISE Internal Reference Solution	2009-08-13
PMN K921718 | JGS Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AUH1016 ISE Low/High Urine Standard	2009-08-13
PMN K921718 | JGS Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AUH1015 ISE High Serum Standard	2009-08-13
PMN K921718 | JGS Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AUH1014 ISE Low Serum Standard	2009-08-13
PMN K921718 | JGS Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AUH1013 ISE Reference Solution	2009-08-13
PMN K921718 | JGS Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AUH1012 ISE Mid Standard Solution	2009-08-13
PMN K921718 | JGS Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	AUH1011 ISE Buffer Solution	2009-08-13
PMN K893628 | CGZ Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	ISE unit for AU analyzers	2009-08-13
PMN K885193 | CGZ Beckman Coulter Mishima K.K. [BECKMAN COULTER, INC.]	ISE unit for AU analyzers	2009-08-13