CANNABINOIDS URINE TEST


Device Classification Name

enzyme immunoassay, cannabinoids

510(k) Number K110182
Device Name CANNABINOIDS URINE TEST
Applicant
Guangzhou Wondfo Biotech Co., Ltd.
504 east diamond ave.
suite f
gaithersburg, 
MD 
20878

Applicant Contact joe shia
Correspondent
Guangzhou Wondfo Biotech Co., Ltd.
504 east diamond ave.
suite f
gaithersburg, 
MD 
20878

Correspodent Contact joe shia
Regulation Number 862.3870
Classification Product Code
LDJ  
Date Received 01/21/2011
Decision Date 05/20/2011
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