ROCHE ACETAMINOPHEN ASSAY


Device Classification Name

colorimetry, acetaminophen

510(k) Number K110726
Device Name ROCHE ACETAMINOPHEN ASSAY
Applicant
Roche Diagnostics
9115 hague road
indianapolis, 
IN 
46250 -0416

Applicant Contact angelo pereira
Correspondent
Roche Diagnostics
9115 hague road
indianapolis, 
IN 
46250 -0416

Correspodent Contact angelo pereira
Regulation Number 862.3030
Classification Product Code
LDP  
Date Received 03/16/2011
Decision Date 12/23/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No