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Immulite Cortisol

by Diagnostic Products Corp.

510(k) K931409

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK931409 Date11 May 1993ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0122-2015 FDA Class II initiated 19 Sep 2014

    Customer complaints were received for positive bias reported on the controls used on the IMMULITE /IMMULITE 1000 on the Cortisol Assay reagent lots IMMULITE /IMMULITE 1000 (LKCO1) Lots 381,382 and 383 . Subsequently, the firm confirmed a positive bias on the IMMULITE/IMMULITE 1000 (LKCO1) Lots 381, 382 and 383.

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  • Withdrawn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
CGR
Device Class
Class II
Regulation
21 CFR Part 862.1205
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 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 IMMULITE CORTISOL is a radioimmunoassay for cortisol, classified under product code CGR and regulation number 862.1205. It is a diagnostic test used in clinical chemistry for the measurement of cortisol levels.

The device was submitted by Diagnostic Products Corp. and received FDA 510(k) clearance under K931409 on May 11, 1993, following a traditional review process. It is classified as a Class II medical device with special controls.

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