UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100


Device Classification Name

analyzer, chemistry (photometric, discrete), for clinical use

510(k) Number K023764
Device Name UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100
Original Applicant
BECKMAN COULTER, INC.
1000 lake hazeltine dr.
chaska, 
MN 
55318 -1084

Original Contact lynn weist
Regulation Number 862.2160
Classification Product Code
JJE  
Subsequent Product Codes
CEC   CGR   CHP   JLW   MMI  
Date Received 11/12/2002
Decision Date 01/28/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls