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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, Nicotine And Nicotine Metabolites
510(k) Number K192299
Device Name LZI Cotinine II Enzyme Immunoassay
Applicant
Lin-Zhi International, Inc.
2945 Oakmead Village Ct.
Santa Clara,  CA  95051
Applicant Contact Bernice Lin
Correspondent
Lin-Zhi International, Inc.
2945 Oakmead Village Ct.
Santa Clara,  CA  95051
Correspondent Contact Bernice Lin
Regulation Number862.3220
Classification Product Code
MKU  
Date Received08/23/2019
Decision Date 11/21/2019
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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