COBAS INTEGRA 400/800 BILIRUBIN TOTAL


Device Classification Name

diazo colorimetry, bilirubin

510(k) Number K081193
Device Name COBAS INTEGRA 400/800 BILIRUBIN TOTAL
Applicant
Roche Diagnostics
9115 hague rd.
indianapolis, 
IN 
46250

Applicant Contact jennifer tribbett
Correspondent
Roche Diagnostics
9115 hague rd.
indianapolis, 
IN 
46250

Correspodent Contact jennifer tribbett
Regulation Number 862.1110
Classification Product Code
CIG  
Date Received 04/28/2008
Decision Date 01/16/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Special
Reviewed by Third Party No

Combination Product

No