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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, Benzodiazepine
510(k) Number K163590
Device Name Psychemedics Microplate EIA for Benzodiazepines 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 Number862.3170
Classification Product Code
JXM  
Date Received12/20/2016
Decision Date 09/15/2017
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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