ROCHE ONLINE TDM PHENYTOIN


Device Classification Name

enzyme immunoassay, diphenylhydantoin

510(k) Number K030428
Device Name ROCHE ONLINE TDM PHENYTOIN
Applicant
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
po bx 50457
indianapolis, 
IN 
46250 -0457

Applicant Contact mike flis
Correspondent
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
po bx 50457
indianapolis, 
IN 
46250 -0457

Correspodent Contact mike flis
Regulation Number 862.3350
Classification Product Code
DIP  
Date Received 02/10/2003
Decision Date 04/28/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls