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Albumin Test (ALB) Item Number: 65401

by Em Diagnostic Systems, Inc. 510(k)

Active United States

510(k) K893777

Overview

The Albumin Test (ALB) is a clinical chemistry device intended to measure albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of diseases primarily involving the liver or kidneys. This device uses the Bromcresol Green Dye-Binding method for albumin determination.

The device is supplied by Em Diagnostic Systems, Inc. and is authorized under FDA 510(k) clearance K893777. It is a Class II medical device with product code CIX. The device is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided.

AI-generated from registry data, 6 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK893777 Date21 Aug 1989ClearedStatusActive

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 22 Oct 2026.

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

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Questions

  • What is the Albumin Test used for?

    The Albumin Test is a clinical chemistry device that measures albumin concentration in serum and plasma, primarily used in the diagnosis and treatment of diseases affecting the liver or kidneys.

  • How is the Albumin Test supplied?

    The Albumin Test is supplied by Em Diagnostic Systems, Inc. as a Class II medical device with product code CIX, authorized under FDA 510(k) clearance K893777.

  • Is the Albumin Test single-use or reusable?

    The device is not specified as single-use or reusable in the provided information, so users should refer to the manufacturer's instructions for specific guidance on usage and disposal.

  • What method does the Albumin Test use for measurement?

    The Albumin Test uses the Bromcresol Green Dye-Binding method for albumin determination, which is a standard technique in clinical chemistry laboratories.