ROCHE ORAL FLUID AMPHETAMINE, ROCHE ORAL FLUID DAT QUAL CAL B, ROCHE ORAL FLUID DAT CONTROL SET B, AND ROCHE ORAL FLUID


Device Classification Name

enzyme immunoassay, amphetamine

510(k) Number K110446
Device Name ROCHE ORAL FLUID AMPHETAMINE, ROCHE ORAL FLUID DAT QUAL CAL B, ROCHE ORAL FLUID DAT CONTROL SET B, AND ROCHE ORAL FLUID
Applicant
Roche Diagnostics
9115 hague road
indianapolis, 
IN 
46250 -0416

Applicant Contact michelle lee neff
Correspondent
Roche Diagnostics
9115 hague road
indianapolis, 
IN 
46250 -0416

Correspodent Contact michelle lee neff
Regulation Number 862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIF   DKB  
Date Received 02/16/2011
Decision Date 05/03/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No