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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Methadone
510(k) Number K152025
Device Name AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)
Applicant
Assure Tech. Co., Ltd.
2nd. Floor, Bldg. 1, #10, Xiyuansan Rd.
Hangzhou,  CN 310030
Applicant Contact ERIC LIN
Correspondent
Lsi International
504 E. Diamond Ave., Suite I
Gaithersburg,  MD  20877
Correspondent Contact JOE SHIA
Regulation Number862.3620
Classification Product Code
DJR  
Subsequent Product Code
DJG  
Date Received07/22/2015
Decision Date 10/05/2015
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
Predetermined Change
Control Plan Authorized		 No
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