510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K904302Substantially Equivalent

Dupont Dimension(r) Ethyl Alcohol(alc) Method

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

K904302 is the FDA 510(k) clearance record for DUPONT DIMENSION(R) ETHYL ALCOHOL(ALC) METHOD, a class II device, cleared for E.I. Dupont DE Nemours & Co., Inc. on under FDA product code DIC (Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method). 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 K904302.

Clearance record

Decision date
Received
(23 days to decision)
Product code
DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Regulation
21 CFR 862.3040
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 DIC

Trailing 12 months

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

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