Skip to content

EDL Normal Coagulation Control

by Elite Diagnostic, Ltd.

510(k) K891179

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 NumberK891179 Date10 Apr 1989ClearedStatusActive

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  • Withdrawn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
GIZ
FDA applicant
Elite Diagnostic , Ltd.
Device Class
Class II
Regulation
21 CFR Part 864.5425
Advisory Committee
Hematology
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.

This device is a normal plasma coagulation control used in hematology to monitor the performance of coagulation testing instruments and reagents. It provides a reference sample with known, stable coagulation parameters to verify the accuracy and precision of clotting assays such as prothrombin time (PT) and activated partial thromboplastin time (aPTT). The control is designed to detect systematic errors or calibration drift in laboratory testing systems.

The device is supplied as a ready-to-use liquid control intended for in vitro diagnostic use in clinical laboratories. It is stored at specified temperatures and handled according to manufacturer instructions to maintain stability. As a Class II device, it is regulated under product code GIZ and was authorized through the FDA 510(k) premarket notification process. The control is intended for single-use or as directed by the laboratory protocol, and it supports quality assurance in hematology testing environments.

Other devices from Elite Diagnostic, Ltd.