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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, Opiates
510(k) Number K201630
Device Name AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests
Applicant
Assure Tech. (Hangzhou) Co, Ltd.
2nd-5th Floor, Bldg. 4, # 1418-50, Moganshan Rd.,
Gongshu District
Hangzhou,  CN 310011
Applicant Contact Shisheng Ling
Correspondent
Lsi International
504 E. Diamond Ave., Suite I
Gaithersburg,  MD  20877
Correspondent Contact Joe Shia
Regulation Number862.3650
Classification Product Code
DJG  
Subsequent Product Codes
DIO   DIS   DJR   DKZ   JXM  
JXN   LAF   LCM   LDJ   LFG  
Date Received06/16/2020
Decision Date 08/12/2021
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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