ACCESS TOTAL T3 ASSAY (MODIFICATION)


Device Classification Name

radioimmunoassay, total triiodothyronine

510(k) Number K955435
Device Name ACCESS TOTAL T3 ASSAY (MODIFICATION)
Applicant
BIO-RAD LABORATORIES, INC.
1000 lake hazeltine dr.
chaska, 
MN 
55318 -1084

Applicant Contact dennis griffin
Correspondent
BIO-RAD LABORATORIES, INC.
1000 lake hazeltine dr.
chaska, 
MN 
55318 -1084

Correspodent Contact dennis griffin
Regulation Number 862.1710
Classification Product Code
CDP  
Date Received 10/02/1995
Decision Date 01/24/1996
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls