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Amerlex Cortisol RIA Kit

by Amersham Corp. 510(k)

Active United States

510(k) K800700

Overview

The Amerlex Cortisol RIA Kit is a radioimmunoassay device used for the quantitative determination of cortisol in human serum or plasma. It is designed for clinical chemistry applications and is intended for in vitro diagnostic use.

The kit is supplied as a single-use, non-sterile product and must be stored according to the manufacturer's instructions. It is regulated under FDA 510(k) clearance (K800700) and is classified as a Class II device.

AI-generated from registry data, 6 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 NumberK800700 Date16 Apr 1980ClearedStatusActive

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  • Withdrawn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 6 Oct 2026.

Specification

510(k)

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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