TECO DIAGNOSTICS SALIVA ALCOHOL TEST


Device Classification Name

alcohol dehydrogenase, specific reagent for ethanol enzyme method

510(k) Number K111206
Device Name TECO DIAGNOSTICS SALIVA ALCOHOL TEST
Applicant
TECO DIAGNOSTICS
1268 north lakeview ave.
anaheim, 
CA 
92807

Applicant Contact james li
Correspondent
TECO DIAGNOSTICS
1268 north lakeview ave.
anaheim, 
CA 
92807

Correspodent Contact james li
Regulation Number 862.3040
Classification Product Code
DIC  
Date Received 04/29/2011
Decision Date 10/04/2011
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