UNISCAN -DOA SYSTEM


Device Classification Name

thin layer chromatography, metamphetamine

510(k) Number K080347
Device Name UNISCAN -DOA SYSTEM
Applicant
TAIWAN UNISON BIOTECH, INC.
3f, no. 22, kedung 3rd road
chunan, miaoli, 

TW

350

Applicant Contact kuang-pin hsiung
Regulation Number 862.3610
Classification Product Code
DJC  
Subsequent Product Codes
DJG   LDJ  
Date Received 02/08/2008
Decision Date 10/09/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party Yes

Combination Product

No