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UC IMU A

by Eucardio Laboratory, Inc. 510(k)

Active United States

510(k) K904125

Overview

UC IMU A is an immunology device classified as an Alpha-1-Lipoprotein, Antigen, Antiserum, Control. It is a device used in immunology testing and laboratory procedures.

The device is manufactured by Eucardio Laboratory, Inc. and received FDA 510(k) clearance on September 24, 1990. It is supplied in various sizes as indicated by the multiple registration numbers. The device is regulated under product code DER and 21 CFR 866.5580.

AI-generated from registry data, 27 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 NumberK904125 Date24 Sep 1990ClearedStatusActive

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 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DER
Device Class
Class II
Regulation
21 CFR Part 866.5580
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

Other devices from Eucardio Laboratory, Inc.

Questions

  • What is the UC IMU A device used for?

    The UC IMU A is an immunology device classified as an Alpha-1-Lipoprotein, Antigen, Antiserum, Control. It is specifically used in immunology testing and laboratory procedures to assist in accurate diagnostic testing.

  • How is the UC IMU A device supplied?

    The UC IMU A is supplied in various sizes as indicated by the multiple registration numbers. This allows laboratories to select the appropriate size for their specific testing needs and volume requirements.

  • What is the regulatory status of the UC IMU A device?

    The UC IMU A received FDA 510(k) clearance on September 24, 1990, and is regulated under product code DER and 21 CFR 866.5580. It is classified as a Class II medical device by the FDA.

  • Is the UC IMU A device single-use or reusable?

    The device data does not specify whether the UC IMU A is designed for single-use or multiple uses. Laboratories should refer to the manufacturer's instructions for use to determine the appropriate handling and disposal procedures for this device.