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Sensibead EIA Digoxin Kit

by Terumo Medical Corp.

510(k) K840673

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK840673 Date12 Mar 1984ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
KXT
Device class
Class II
Regulation
21 CFR Part 862.3320
Advisory committee
Clinical Toxicology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is an Enzyme Immunoassay for Digoxin, as defined by its device type and nomenclature. It is a diagnostic test kit used to measure digoxin levels in clinical specimens.

It is supplied as a kit for in vitro diagnostic use, cleared by the FDA through the 510(k) pathway (K840673) and classified as a Class II device with product code KXT. The device is intended for use in clinical laboratory settings under special controls for Clinical Toxicology.

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