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Mcs Albumin Reagent

by Medilab Corp.

510(k) K840291

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 NumberK840291 Date30 Mar 1984ClearedStatusActive

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  • Withdrawn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
CIX
Device Class
Class II
Regulation
21 CFR Part 862.1035
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Mcs Albumin Reagent is a device used in Clinical Chemistry for the Bromcresol Green Dye-binding, Albumin test. It is classified as a Class 2 device. The device is substantially equivalent to other devices on the market.

The Mcs Albumin Reagent is supplied with a product code of CIX and a regulation number of 862.1035. It has been authorized by the FDA with a 510K number of K840291. The device is used in clinical chemistry settings and is intended for use in the measurement of albumin levels.

Other devices from Medilab Corp.

  • Immu-Tec

    Class II

  • Mono-Tec

    Class II

  • Pregna-Tec

    Class II

  • Mcs Total Protein Reagent

    Class II

  • Lyse-Tec

    Class I

  • Pregna-Tec

    Class II

Questions

AI-generated answers, 27 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 MCS Albumin Reagent used for?

    The MCS Albumin Reagent is used for measuring albumin levels in clinical chemistry settings with the Bromcresol Green Dye-binding test, providing a diagnostic tool for clinicians.

  • What is the regulatory classification of the MCS Albumin Reagent?

    The MCS Albumin Reagent is classified as a Class 2 device, indicating a moderate level of risk and requiring special controls to ensure safety and effectiveness.

  • How has the MCS Albumin Reagent been authorized?

    The MCS Albumin Reagent has been authorized by the FDA with a 510K number of K840291, indicating that it is substantially equivalent to other devices on the market.

  • What product code is associated with the MCS Albumin Reagent?

    The MCS Albumin Reagent has a product code of CIX, which is used for regulatory and identification purposes.