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Coulter Clone T4 Monoclonal Antibody

by Coulter Immunology

510(k) K893852

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK893852 Date2 Mar 1990ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
GKZ
Device Class
Class II
Regulation
21 CFR Part 864.5220
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

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

The Coulter Clone T4 Monoclonal Antibody is a Counter, Differential Cell device used in hematology. It is a monoclonal antibody reagent designed for the identification and enumeration of T4 lymphocytes in blood samples.

This device is supplied as a reagent for in vitro diagnostic use in clinical laboratory settings. It is authorized under FDA 510(k) clearance K893852, classified as a Class II device with product code GKZ, and received clearance on March 2, 1990, following submission on May 25, 1989.

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Questions

AI-generated answers, 25 Sep 2026

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

  • What is the Coulter Clone T4 Monoclonal Antibody used for?

    The Coulter Clone T4 Monoclonal Antibody is used to identify and enumerate T4 lymphocytes in blood samples as part of hematology testing. It functions as a monoclonal antibody reagent in a Counter, Differential Cell device for in vitro diagnostic use in clinical laboratories.

  • How is the Coulter Clone T4 Monoclonal Antibody supplied and intended for use?

    It is supplied as a reagent for in vitro diagnostic use in clinical laboratory settings. The device is designed for use with blood samples to detect and count T4 lymphocytes, supporting hematological analysis.

  • What regulatory authorization does the Coulter Clone T4 Monoclonal Antibody have?

    The device is authorized under FDA 510(k) clearance K893852, received on March 2, 1990, following a submission on May 25, 1989. It is classified as a Class II device with product code GKZ and regulation number 864.5220.