ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801


Device Classification Name

turbidimetric, total protein

510(k) Number K072638
Device Name ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801
Applicant
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
indianapolis, 
IN 
46250

Applicant Contact kerwin l kaufman
Correspondent
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
indianapolis, 
IN 
46250

Correspodent Contact kerwin l kaufman
Regulation Number 862.1635
Classification Product Code
JGQ  
Date Received 09/18/2007
Decision Date 10/19/2007
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