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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 north cleveland
mogadore,  OH  44260
Contact robert j bard
Regulation Number862.3870
Classification Product Code
LDJ  
Date Received09/10/2012
Decision Date 12/05/2012
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Toxicology
Review Advisory Committee Toxicology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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