Skip to content

Eldoncard

by Nordisk Infuser System

510(k) K790282

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 NumberK790282 Date4 May 1979ClearedStatusActive

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  • Withdrawn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
KSZ
Device Class
Class II
Regulation
21 CFR Part 864.9175
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 Eldoncard is an automated blood grouping and antibody test system. It is designed to facilitate the identification of blood types and associated antibodies.

This device is classified as a class 2 medical device under regulation number 864.9175. It has received FDA 510(k) clearance under the identifier K790282.

Other devices from Nordisk Infuser System

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 primary function of the Eldoncard?

    The Eldoncard is an automated blood grouping and antibody test system. It is specifically designed to facilitate the identification of blood types and the detection of associated antibodies in a clinical setting.

  • What is the regulatory status of this device?

    The Eldoncard is classified as a class 2 medical device under regulation number 864.9175. It has received FDA 510(k) clearance under the identifier K790282, which indicates that the device has been found to be substantially equivalent to other legally marketed devices.

  • Which medical specialty uses the Eldoncard?

    The Eldoncard is categorized under the Hematology medical specialty. This classification reflects its intended use in blood grouping and antibody testing procedures.