ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS


Device Classification Name

radioimmunoassay, free thyroxine

510(k) Number K080167
Device Name ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
511 benedict avenue
tarrytown, 
NY 
10591

Applicant Contact philip liu
Correspondent
SIEMENS HEALTHCARE DIAGNOSTICS
511 benedict avenue
tarrytown, 
NY 
10591

Correspodent Contact philip liu
Regulation Number 862.1695
Classification Product Code
CEC  
Date Received 01/23/2008
Decision Date 08/08/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No