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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 K113747
Device Name RANDOX OPIATES ASSAY
Original Applicant
RANDOX LABORATORIES LIMITED
55 diamond road
crumlin,  GB bt29 4qy
Original Contact pauline armstrong
Regulation Number862.3650
Classification Product Code
DJG  
Subsequent Product Codes
DLJ   LAS  
Date Received12/20/2011
Decision Date 08/24/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
statement statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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