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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name organophosphate test system
510(k) Number K122282
Device Name QUANTITATION OF ORGANOPHOSPHATE METABOLITES IN URINE BY LC/MS/MS
Original Applicant
CENTERS FOR DISEASE CONTROL AND PREVENTION
4770 buford hwy n.e.
atlanta,  GA  30341
Original Contact elizabeth hamelin
Regulation Number862.3652
Classification Product Code
PDY  
Date Received07/30/2012
Decision Date 08/08/2013
Decision de novo petitions granted (AN)
Classification Advisory Committee Toxicology
Review Advisory Committee Toxicology
FOI Item Approval Letter
FDA Review Decision Summary
Type De Novo Petitions Granted
Reviewed by Third Party No
Expedited Review No
Combination Product No
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