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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 K192517
Device Name Psychemedics Microplate EIA for Cotinine in Hair
Applicant
Psychemedics Corporation
5832 Uplander Way
Culver City,  CA  90230
Applicant Contact Virginia Hill
Correspondent
Psychemedics Corporation
5832 Uplander Way
Culver City,  CA  90230
Correspondent Contact Virginia Hill
Regulation Number862.3220
Classification Product Code
MKU  
Date Received09/13/2019
Decision Date 04/22/2020
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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