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Delfia Triiodothyronine (T3) Kit

by Pharmacia, Inc.

510(k) K883810

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK883810 Date2 Dec 1988ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
CDP
Device Class
Class II
Regulation
21 CFR Part 862.1710
Advisory Committee
Clinical Chemistry
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.

The Delfia Triiodothyronine (T3) Kit is a radioimmunoassay device for measuring total triiodothyronine. It is classified as a clinical chemistry device. The kit is used for in vitro diagnostic purposes.

The device is supplied as a kit and is intended for single-use. It is regulated under the product code CDP and has been cleared by the FDA under the 510(k) clearance process, with the clearance number K883810. The device is stored at a location with the address 800 Centennial Ave, Piscataway, NJ 08854.

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Questions

AI-generated answers, 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.

  • What is the Delfia T3 Kit used for?

    The Delfia T3 Kit is used for measuring total triiodothyronine for in vitro diagnostic purposes, specifically in clinical chemistry.

  • Is the Delfia T3 Kit supplied as a single-use device?

    Yes, the Delfia T3 Kit is intended for single-use and is supplied as a kit.

  • How is the Delfia T3 Kit regulated?

    The Delfia T3 Kit is regulated under the product code CDP and has been cleared by the FDA under the 510(k) clearance process.