510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K891094Substantially Equivalent

Aca(r) Digitoxin (Dgtx) Method

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

K891094 is the FDA 510(k) clearance record for ACA(R) DIGITOXIN (DGTX) METHOD, a class II device, cleared for E.I. Dupont DE Nemours & Co., Inc. on under FDA product code LFM (Enzyme Immunoassay, Digitoxin). 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 K891094.

Clearance record

Decision date
Received
(55 days to decision)
Product code
LFM Enzyme Immunoassay, Digitoxin
Regulation
21 CFR 862.3300
Device class
Class II
Review panel
Clinical Toxicology
Applicant
E.I. Dupont DE Nemours & Co., Inc. Medical Products Dept., Wilmington DE
Third party review
No

Clearances, product code LFM

Trailing 12 months

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

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