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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 K182103
Device Name Psychemedics Microplate EIA for Fentanyl 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 Number862.3650
Classification Product Code
DJG  
Date Received08/03/2018
Decision Date 04/18/2019
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
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