510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
DEN130005Unknown

Quantitation of Organophosphate Metabolites in Urine by Lc/ms/ms

Centers for Disease Control and Prevention, Atlanta GA / Post-NSE, Unknown
FDA source (opens on fda.gov)

DEN130005 is the FDA 510(k) clearance record for QUANTITATION OF ORGANOPHOSPHATE METABOLITES IN URINE BY LC/MS/MS, a class II device, cleared for Centers for Disease Control and Prevention on under FDA product code PDY (Organophosphate Test System). FDA's definition for product code PDY reads: "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...". FDA records list 30 510(k) clearances for Centers for Disease Control and Prevention, from to . As of , FDA records show no recalls naming DEN130005.

Clearance record

Decision date
Received
(72 days to decision)
Product code
PDY Organophosphate Test System
Regulation
21 CFR 862.3652
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Centers for Disease Control and Prevention 4770 Buford Hwy. NE, Atlanta GA
Third party review
No

Clearances, product code PDY

Trailing 12 months

FDA records hold no clearances under product code PDY in the trailing twelve months.

FDA records show no clearances under product code PDY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PDY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260