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Serum Total Protein Reagent Set

by Medical Specialties, Inc. 510(k)

Active United States

510(k) K841069

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK841069 Date1 May 1984ClearedStatusActive

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  • Withdrawn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.

This device is a Biuret (Colorimetric) Total Protein Reagent Set, designed for quantitative measurement of total protein concentration in serum samples. It employs a colorimetric assay based on the biuret reaction to determine protein levels, providing a reliable analytical tool for clinical chemistry applications.

The reagent set is intended for use in clinical laboratories and is supplied as a multi-component kit for in vitro diagnostic testing. It is classified as a Class II device under FDA regulations (510(k) K841069) and has been cleared as substantially equivalent to predicate devices. No information regarding sterility, single-use, or MRI safety is provided in the specifications.

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