Skip to content

Progene Ige Test

by Progene Corp.

510(k) K875125

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 NumberK875125 Date25 Feb 1988ClearedStatusActive

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  • Withdrawn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)

Full name
Progene(Tm) Ige Test
510(k) Number
FDA Product Code
DHB
Device Class
Class II
Regulation
21 CFR Part 866.5750
Advisory Committee
Immunology
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 Progene Ige Test is a radioallergosorbent test system used for immunological diagnostic purposes. It is classified as a class 2 medical device intended for the detection of specific IgE antibodies.

This device is regulated under 21 CFR 866.5750 and received FDA 510(k) clearance under K875125. It is manufactured by Progene Corp. and is categorized under the immunology medical specialty.

Other devices from Progene Corp.

Questions

AI-generated answers, 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.

  • What is the Progene Ige Test used for?

    The Progene Ige Test is a radioallergosorbent test system designed for immunological diagnostic purposes. It is specifically intended for the detection of specific IgE antibodies in a clinical setting.

  • What is the regulatory status of this test system?

    This device is classified as a class 2 medical device and is regulated under 21 CFR 866.5750. It received FDA 510(k) clearance under the submission number K875125.

  • Who manufactures the Progene Ige Test and what is its medical specialty?

    The Progene Ige Test is manufactured by Progene Corp., which is based in Overland Park, Kansas. It falls under the immunology medical specialty and is categorized with the product code DHB.