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Total Protein Reagent

by Medical Analysis Systems, Inc. 510(k)

Active United States

510(k) K890317

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK890317 Date8 Mar 1989ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • 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
CEK
Device Class
Class II
Regulation
21 CFR Part 862.1635
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Total Protein Reagent is a Biuret (Colorimetric) Total Protein diagnostic device, classified as a Class II medical device. It quantifies total protein levels in serum or plasma using a colorimetric reaction, aiding in the assessment of liver, kidney, bone marrow function, and metabolic or nutritional disorders.

This reagent is supplied as a liquid reagent for in vitro diagnostic use in clinical chemistry laboratories. It is intended for single-use applications and requires no special storage conditions beyond those specified in the manufacturer’s instructions. The device holds an FDA 510(k) clearance (K890317) under the regulatory framework for clinical chemistry reagents, with no third-party certification noted.

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