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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
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