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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 K210212
Device Name Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair
Applicant
Psychemedics Corporation
5832 Uplander Way
Culver City,  CA  90230
Applicant Contact Neil Stowe
Correspondent
Psychemedics Corporation
5832 Uplander Way
Culver City,  CA  90230
Correspondent Contact Neil Stowe
Regulation Number862.3610
Classification Product Code
LAF  
Subsequent Product Code
DKZ  
Date Received01/27/2021
Decision Date 12/15/2021
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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