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Centria Cortisol Radioimmunoassay

by Union Carbide Corp. 510(k)

Active United States

510(k) K780725

Overview

The Centria Cortisol Radioimmunoassay is a diagnostic in vitro device classified as a radioimmunoassay for cortisol measurement. It employs radioisotope-based technology to quantify cortisol levels in serum or plasma samples, aiding in the assessment of adrenal function and endocrine disorders. This method relies on competitive binding between labeled and unlabeled cortisol to determine concentration through radioactive detection.

This device is supplied as a test kit for laboratory use, requiring specialized handling and compliance with radiation safety protocols. It is intended for single-use and must be stored under controlled conditions to maintain stability. The Centria Cortisol Radioimmunoassay holds FDA 510(k) clearance (K780725) and falls under the Clinical Chemistry advisory committee classification, adhering to regulatory standards for in vitro diagnostics. No information regarding MRI safety or reusable components is provided in the specifications.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK780725 Date6 Jun 1978ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 5 Oct 2026.

Specification

510(k)

Full name
Centria Cortisol Ria
510(k) Number
FDA Product Code
CGR
Device Class
Class II
Regulation
21 CFR Part 862.1205
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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