SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722


Device Classification Name

colorimetry, cholinesterase

510(k) Number K103373
Device Name SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722
Applicant
BECKMAN COULTER, INC.
250 s. kraemer boulevard
brea, 
CA 
92821

Applicant Contact yvette lloyd
Correspondent
BECKMAN COULTER, INC.
250 s. kraemer boulevard
brea, 
CA 
92821

Correspodent Contact yvette lloyd
Regulation Number 862.3240
Classification Product Code
DIH  
Date Received 11/17/2010
Decision Date 02/07/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No