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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 K253082
Device Name LZI Buprenorphine II Enzyme Immunoassay
Applicant
Lin-Zhi International, Inc.
2945 Oakmead Village Ct.
Santa Clara,  CA  95051
Applicant Contact Thet Wai
Correspondent
Lin-Zhi International, Inc.
2945 Oakmead Village Ct.
Santa Clara,  CA  95051
Correspondent Contact Thet Wai
Regulation Number862.3650
Classification Product Code
DJG  
Date Received09/23/2025
Decision Date 01/16/2026
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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