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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, Phencyclidine
510(k) Number K131181
Device Name OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE
Applicant
Omega Laboratories, Inc.
400 N. Cleveland
Mogadore,  OH  44260
Applicant Contact ROBERT J BARD, JD, RAC, CQE
Correspondent
Omega Laboratories, Inc.
400 N. Cleveland
Mogadore,  OH  44260
Correspondent Contact ROBERT J BARD, JD, RAC, CQE
Classification Product Code
LCM  
Date Received04/25/2013
Decision Date 06/25/2013
Decision Substantially Equivalent (SESE)
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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