UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0


Device Classification Name

glucose oxidase, glucose

510(k) Number K103842
Device Name UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0
Applicant
BECKMAN COULTER, INC.
250 s. kraemer boulevard
mail stop e2 se08
brea, 
CA 
92821

Applicant Contact marine boyajian
Correspondent
BECKMAN COULTER, INC.
250 s. kraemer boulevard
mail stop e2 se08
brea, 
CA 
92821

Correspodent Contact marine boyajian
Regulation Number 862.1345
Classification Product Code
CGA  
Subsequent Product Code
JJE  
Date Received 12/30/2010
Decision Date 04/27/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls