COBAS INTEGRA ALP IFCC GEN.2

Device Classification Name

nitrophenylphosphate, alkaline phosphatase or isoenzymes

510(k) Number K033185
Device Name COBAS INTEGRA ALP IFCC GEN.2
Applicant
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
indianapolis, 
IN 
46250

Applicant Contact sherri l coenen
Correspondent
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
indianapolis, 
IN 
46250

Correspodent Contact sherri l coenen
Regulation Number 862.1050
Classification Product Code
CJE  
Date Received 10/01/2003
Decision Date 10/14/2003
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