UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS

Electrode, Ion Specific, Potassium

The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Unicel Dxc 600 And 800 Synchron Systems.

Device ID	K042291
510k Number	K042291
Device Name:	UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS
Classification	Electrode, Ion Specific, Potassium
Applicant	BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD.,W-104 P.O. BOX 8000 Brea, CA 92822 -8000
Contact	Mary Beth Tang
Correspondent	Mary Beth Tang BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD.,W-104 P.O. BOX 8000 Brea, CA 92822 -8000
Product Code	CEM
Subsequent Product Code	CEK
Subsequent Product Code	CEO
Subsequent Product Code	CFJ
Subsequent Product Code	CGA
Subsequent Product Code	CGX
Subsequent Product Code	CJW
Subsequent Product Code	DCK
Subsequent Product Code	DLZ
Subsequent Product Code	JFL
Subsequent Product Code	JFP
Subsequent Product Code	JGJ
Subsequent Product Code	JGS
Subsequent Product Code	JIY
Subsequent Product Code	JJE
Subsequent Product Code	JXM
Subsequent Product Code	LFP
CFR Regulation Number	862.1600 [🔎]
Decision	Substantially Equivalent (SESE)
Type	Traditional
3rd Party Reviewed	No
Combination Product	No
Date Received	2004-08-24
Decision Date	2004-11-12
Summary:	summary