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510(k) DEN130005

QUANTITATION OF ORGANOPHOSPHATE METABOLITES IN URINE BY LC/MS/MS by Centers for Disease Control and Prevention — Product Code PDY

DEN130005 is an FDA 510(k) premarket notification submitted by Centers for Disease Control and Prevention for the device "QUANTITATION OF ORGANOPHOSPHATE METABOLITES IN URINE BY LC/MS/MS". The FDA issued a decision of De Novo Granted on August 8, 2013. The device falls under product code PDY (Organophosphate Test System), a Class II device regulated under 21 CFR 862.3652. Centers for Disease Control and Prevention has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
August 8, 2013
Date Received
May 28, 2013
Clearance Type
Post-NSE
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Organophosphate Test System
Device Class
Class II
Regulation Number
862.3652
Review Panel
TX
Submission Type

For the quantitation of specific organophosphate metabolites in human urine from individuals who have signs and symptoms consistent with cholinesterase poisoning. The data obtained by this device is intended to aid in the confirmation and investigation of organophosphate exposure.

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