Skip to content

Digoxin Fpia Reagent Set

by Sigma Diagnostics, Inc. 510(k)

Active United States

510(k) K870951

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK870951 Date1 Apr 1987ClearedStatusActive

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  • Withdrawn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 6 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

Overview

AI-generated summary, 26 Sep 2026

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

The Digoxin Fpia Reagent Set is an enzyme immunoassay device used to measure the concentration of digoxin, a cardiovascular drug, in serum and plasma. These measurements are utilized in the diagnosis and treatment of digoxin overdose and to monitor drug levels to ensure appropriate therapy.

This device is authorized under FDA 510(k) clearance K870951. It is classified under regulation number 862.3320 within the clinical toxicology specialty.

Other devices from Sigma Diagnostics, Inc.

See all devices from Sigma Diagnostics, Inc. →