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Ortho T-4 Ria (Peg) Kit

by Ortho Diagnostics, Inc.

510(k) K781483

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 NumberK781483 Date27 Sep 1978ClearedStatusActive

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  • Withdrawn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
CDX
Device Class
Class II
Regulation
21 CFR Part 862.1700
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Ortho T-4 Ria (Peg) Kit is a radioimmunoassay device used for the measurement of total thyroxine. It functions as an in vitro diagnostic tool within the field of clinical chemistry.

This device has received FDA 510(k) clearance. It is categorized under regulation number 862.1700 and product code CDX.

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