510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K781941Substantially Equivalent

Analysis System, Prep Sample

E.I. Dupont de Nemours & Co., Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K781941 is the FDA 510(k) clearance record for ANALYSIS SYSTEM, PREP SAMPLE, a class II device, cleared for E.I. Dupont DE Nemours & Co., Inc. on under FDA product code DOZ (Liquid Chromatography, Diphenylhydantoin). FDA records list 253 510(k) clearances for E.I. Dupont DE Nemours & Co., Inc., from to . As of , FDA records show no recalls naming K781941.

Clearance record

Decision date
Received
(44 days to decision)
Product code
DOZ Liquid Chromatography, Diphenylhydantoin
Regulation
21 CFR 862.3350
Device class
Class II
Review panel
Clinical Toxicology
Applicant
E.I. Dupont DE Nemours & Co., Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DOZ

Trailing 12 months

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

FDA records show no clearances under product code DOZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DOZ, 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