Skip to content

GTI-PF4 Elisa

by Genetic Testing Institute

510(k) K983379

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 NumberK983379 Date9 Mar 1999ClearedStatusActive

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  • Withdrawn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
LCO
Device Class
Class II
Regulation
21 CFR Part 864.7695
Advisory Committee
Hematology
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.

The Gti-Pf4 Elisa is a solid phase enzyme-linked immunosorbent assay (ELISA) designed to test for Platelet Factor 4. It is classified as a Platelet Factor 4 Radioimmunoassay, with a product code of LCO.

The device is supplied as a Class II device, with special controls, and is used in the field of Hematology. It is available in various sizes, as indicated by its fei numbers, and is stored according to standard procedures. The device has been cleared by the FDA, with a 510(k) clearance number of K983379, and is registered with the FDA under several registration numbers.

Other devices from Genetic Testing Institute

Questions

AI-generated answers, 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.

  • What is the GTI-PF4 ELISA used for?

    The GTI-PF4 ELISA is used to test for Platelet Factor 4, which is an application in the field of Hematology.

  • How is the GTI-PF4 ELISA supplied?

    The device is supplied as a Class II device, with special controls, and is available in various sizes as indicated by its FEI numbers.

  • What is the regulatory status of the GTI-PF4 ELISA?

    The device has been cleared by the FDA with a 510(k) clearance number of K983379, indicating it is substantially equivalent to a predicate device.

  • How should the GTI-PF4 ELISA be stored?

    The device should be stored according to standard procedures, although specific storage instructions are not provided.