POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS


Device Classification Name

radioassay, vitamin b12

510(k) Number K110413
Device Name POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS
Applicant
BECKMAN COULTER, INC.
250 south kraemer blvd
brea, 
CA 
92822

Applicant Contact marine boyajian
Correspondent
BECKMAN COULTER, INC.
250 south kraemer blvd
brea, 
CA 
92822

Correspodent Contact marine boyajian
Regulation Number 862.1810
Classification Product Code
CDD  
Subsequent Product Codes
CGN   DBF   JJE   JLW  
Date Received 02/14/2011
Decision Date 05/11/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Special
Reviewed by Third Party No

Combination Product

No