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ACTH RIA

by Syncor Intl. Corp. 510(k)

Active United States

510(k) K844181

Overview

ACTH RIA is a radioimmunoassay device used for measuring adrenocorticotropic hormone (ACTH) levels in clinical chemistry applications. This device is designed to provide quantitative analysis of ACTH in patient samples.

The ACTH RIA is supplied as a Class 2 device with FDA 510(k) clearance K844181, granted on November 27, 1984. It is regulated under 862.1025 and is intended for clinical chemistry laboratory use. The device is manufactured by Syncor Intl. Corp. and is available in various configurations as specified by the manufacturer.

AI-generated from registry data, 27 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK844181 Date27 Nov 1984ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
CKG
Device Class
Class II
Regulation
21 CFR Part 862.1025
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the ACTH RIA device used for?

    The ACTH RIA is a radioimmunoassay device designed for quantitative analysis of adrenocorticotropic hormone (ACTH) levels in patient samples, specifically for clinical chemistry laboratory applications.

  • How is the ACTH RIA device supplied?

    The ACTH RIA is supplied as a Class 2 device manufactured by Syncor Intl. Corp. It is available in various configurations as specified by the manufacturer for clinical chemistry laboratory use.

  • What is the regulatory status of the ACTH RIA device?

    The ACTH RIA has FDA 510(k) clearance K844181, granted on November 27, 1984, and is regulated under 862.1025. It is classified as substantially equivalent and reviewed under the Clinical Chemistry advisory committee.

  • Is the ACTH RIA device single-use or reusable?

    The device data does not specify whether the ACTH RIA is designed for single-use or multiple uses. The manufacturer's instructions should be consulted for proper handling and disposal procedures.