ACCESS TOTAL T4 ASSAY


Device Classification Name

enzyme immunoassay, non-radiolabeled, total thyroxine

510(k) Number K023369
Device Name ACCESS TOTAL T4 ASSAY
Original Applicant
BECKMAN COULTER, INC.
1000 lake hazeltine dr.
chaska, 
MN 
55318 -1084

Original Contact denise thompson
Regulation Number 862.1700
Classification Product Code
KLI  
Subsequent Product Code
JIS  
Date Received 10/08/2002
Decision Date 12/09/2002
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