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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Cocaine Metabolite
510(k) Number K010868
Device Name PSYCHEMEDICS RIA COCAINE ASSAY
Applicant
Psychemedics Corp.
5832 Uplander Way
Culver City,  CA  90230
Applicant Contact THOMAS CAIRNS
Correspondent
Psychemedics Corp.
5832 Uplander Way
Culver City,  CA  90230
Correspondent Contact THOMAS CAIRNS
Regulation Number862.3250
Classification Product Code
KLN  
Date Received03/23/2001
Decision Date 11/06/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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