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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name organophosphate test system
De Novo Number DEN130005
510(K) Number K122282
Device Name QUANTITATION OF ORGANOPHOSPHATE METABOLITES IN URINE BY LC/MS/MS
Requester
centers for disease control and prevention
4770 buford hwy ne
atlanta,  GA  30341
Contact elizabeth hamelin
Regulation Number862.3652
Classification Product Code
PDY  
Date Received05/28/2013
Decision Date 08/08/2013
Decision granted (DENG)
Classification Advisory Committee Toxicology
Review Advisory Committee Toxicology
Classification Order Classification Order
FDA Review Decision Summary
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
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