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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, Cannabinoids
510(k) Number K122759
Device Name OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA)
Applicant
Omega Laboratories, Inc.
400 N. Cleveland
Mogadore,  OH  44260
Applicant Contact ROBERT J BARD
Correspondent
Omega Laboratories, Inc.
400 N. Cleveland
Mogadore,  OH  44260
Correspondent Contact ROBERT J BARD
Regulation Number862.3870
Classification Product Code
LDJ  
Date Received09/10/2012
Decision Date 12/05/2012
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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