Skip to content

Fast Digoxin Test System

by Diatron Corp. 510(k)

Active United States

510(k) K924504

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK924504 Date13 Jan 1993ClearedStatusActive

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  • Withdrawn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 11 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KXT
Device Class
Class II
Regulation
21 CFR Part 862.3320
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent