AU5800(R) CHEMISTRY ANALYZER


Device Classification Name

electrode, ion specific, potassium

510(k) Number K112412
Device Name AU5800(R) CHEMISTRY ANALYZER
Applicant
BECKMAN COULTER, INC.
250 s. kraemer boulevard
mail stop e2 se08
brea, 
CA 
92821

Applicant Contact david g davis
Correspondent
BECKMAN COULTER, INC.
250 s. kraemer boulevard
mail stop e2 se08
brea, 
CA 
92821

Correspodent Contact david g davis
Regulation Number 862.1600
Classification Product Code
CEM  
Subsequent Product Codes
CFR   JGJ   JJE  
Date Received 08/22/2011
Decision Date 12/23/2011
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