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American Bio-Science Lab Cortisol Reagent

by American Bio-Science Laboratories

510(k) K842455

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 NumberK842455 Date16 Aug 1984ClearedStatusActive

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  • Withdrawn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)

Full name
Amer. Bio-Science Lab Cortisol Reagent
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, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a radioimmunoassay reagent for cortisol, classified under the Clinical Chemistry specialty. It is intended for use in laboratory settings to measure cortisol levels in patient specimens.

The reagent is supplied as an in vitro diagnostic product and has received FDA 510(k) clearance under K842455, with a decision of substantially equivalent. It is regulated as a Class II medical device under regulation number 862.1205 and product code CGR.

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