Skip to content

Immuchem Covalent Coat Solid Phase Assay

by Immuchem Corp. 510(k)

Active United States

510(k) K791663

Overview

The Immuchem Covalent Coat Solid Phase Assay is a radioimmunoassay designed to measure total triiodothyronine (T3) in clinical specimens. It utilizes a covalent coating on a solid phase to capture the target analyte and employs a radiolabeled tracer for quantitative detection in a clinical chemistry setting.

The assay is supplied as a kit for use in laboratory environments and is classified as a Class II medical device (product code CDP) under FDA regulation 862.1710. It received traditional 510(k) clearance (K791663) with a decision of Substantially Equivalent on 1979‑10‑01, reviewed by the Clinical Chemistry advisory committee. The device is not third‑party reviewed and is intended for single‑use application in accordance with the manufacturer’s instructions.

AI-generated from registry data, 26 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK791663 Date1 Oct 1979ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
CDP
Device Class
Class II
Regulation
21 CFR Part 862.1710
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Other devices from Immuchem Corp.

See all devices from Immuchem Corp. →

Questions

  • What is the Immuchem Covalent Coat Solid Phase Assay used for?

    The assay is designed to measure total triiodothyronine (T3) in clinical specimens. It uses a covalent coating on a solid phase to capture the target analyte and a radiolabeled tracer for quantitative detection in a clinical chemistry setting.

  • How is the Immuchem Covalent Coat Solid Phase Assay supplied and intended for use?

    The assay is supplied as a kit for use in laboratory environments and is intended for single-use application in accordance with the manufacturer’s instructions.

  • What regulatory pathway and classification apply to the Immuchem Covalent Coat Solid Phase Assay?

    The device is classified as a Class II medical device under FDA regulation 862.1710 with product code CDP. It received traditional 510(k) clearance (K791663) on 1979-10-01 with a decision of Substantially Equivalent, reviewed by the Clinical Chemistry advisory committee.