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Ethanol-L3K Assay, Models 273-30, 273-17, 273-10

by Diagnostic Chemicals, Ltd.

510(k) K001286

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 11 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK001286 Date20 Jun 2000ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 11 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DIC
Models / Variants
FDA applicant
Diagnostic Chemicals , Ltd.
Device Class
Class II
Regulation
21 CFR Part 862.3040
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

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