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Coat-A-Count Free Thyroxine Kit/Componen

by Diagnostic Products Corp.

510(k) K822882

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 NumberK822882 Date5 Nov 1982ClearedStatusActive

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  • Withdrawn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)

510(k) Number
FDA Product Code
CEC
Device Class
Class II
Regulation
21 CFR Part 862.1695
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 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 Coat-A-Count Free Thyroxine Kit is a radioimmunoassay device used for the measurement of free thyroxine in clinical chemistry applications. It functions as a diagnostic test to determine the concentration of this hormone in patient samples.

This device is supplied by Diagnostic Products Corp. and has received FDA 510(k) clearance under the regulation number 862.1695. It is categorized under the clinical chemistry medical specialty.

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