ACCESS TOTAL BHCG


Device Classification Name

visual, pregnancy hcg, prescription use

510(k) Number K023480
Device Name ACCESS TOTAL BHCG
Original Applicant
BECKMAN COULTER, INC.
1000 lake hazeltine dr.
chaska, 
MN 
55318 -1084

Original Contact denise thompson
Regulation Number 862.1155
Classification Product Code
JHI  
Subsequent Product Code
JIT  
Date Received 10/17/2002
Decision Date 12/20/2002
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