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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 K201938
Device Name LZI Fentanyl II Enzyme Immunoassay
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 Number862.3650
Classification Product Code
DJG  
Date Received07/13/2020
Decision Date 08/07/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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