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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gas Chromatography, Methamphetamine
510(k) Number K203647
Device Name SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay
Applicant
Immunalysis Corporation
829 Towne Center Dr.
Pomona,  CA  91767
Applicant Contact Wenying (Jessica) Zhu
Correspondent
Immunalysis Corporation
829 Towne Center Dr.
Pomona,  CA  91767
Correspondent Contact Elina Arroyo
Regulation Number862.3610
Classification Product Code
LAF  
Date Received12/14/2020
Decision Date 12/22/2021
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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