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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 K170416
Device Name LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators
Applicant
Lin-Zhi International, Inc.
2945 Oakmead Village Court
Santa Clara,  CA  95051
Applicant Contact Bernice Lin
Correspondent
Lin-Zhi International, Inc.
2945 Oakmead Village Court
Santa Clara,  CA  95051
Correspondent Contact Bernice Lin
Regulation Number862.3620
Classification Product Code
DJR  
Subsequent Product Code
DLJ  
Date Received02/10/2017
Decision Date 06/26/2017
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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