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Demand Ethyl Alcohol

by Cooper Biomedical, Inc. 510(k)

Active United States

510(k) K854130

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK854130 Date5 Nov 1985ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 10 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DIC
Device Class
Class II
Regulation
21 CFR Part 862.3040
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

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