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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Tricyclic Antidepressant Drugs
510(k) Number K112395
Device Name WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST
Applicant
Guangzhou Wondfo Biotech Co., Ltd.
504 E. Diamond Ave. Suite F
Gaithersburg,  MD  20878
Applicant Contact Joe Shia
Correspondent
Guangzhou Wondfo Biotech Co., Ltd.
504 E. Diamond Ave. Suite F
Gaithersburg,  MD  20878
Correspondent Contact Joe Shia
Regulation Number862.3910
Classification Product Code
LFG  
Subsequent Product Code
LCM  
Date Received08/19/2011
Decision Date 09/09/2011
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
Predetermined Change
Control Plan Authorized		 No
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