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Glucose Tolerance Beverage

by Ever Scientific 510(k)

Active United States

510(k) K042183

Overview

A Glucose Tolerance Beverage is a drink used for glucose tolerance testing in clinical chemistry. It is a substantially equivalent device cleared through the FDA 510(k) process under product code MRV and regulation number 862.1345.

It is supplied as a ready-to-drink solution for oral glucose tolerance testing, typically used in clinical settings under the supervision of a test administrator. The beverage is provided in various flavors and sizes, such as 50 g or 100 g glucose loads, and is intended for single use during diagnostic testing procedures.

AI-generated from registry data, 1 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 NumberK042183 Date27 Oct 2004ClearedStatusActive

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

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0329-2017 FDA Class II initiated 24 Aug 2016
    • Terminated Z-0330-2017 FDA Class II initiated 24 Aug 2016

    Out of Specification Microbiological test results

Specification

510(k)

510(k) Number
FDA Product Code
MRV
Device Class
Class II
Regulation
21 CFR Part 862.1345
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Questions

  • What is the Glucose Tolerance Beverage used for?

    The Glucose Tolerance Beverage is used for glucose tolerance testing in clinical chemistry to assess how the body processes sugar, administered orally under supervision during diagnostic procedures.

  • How is the Glucose Tolerance Beverage supplied and is it reusable?

    It is supplied as a ready-to-drink solution in various flavors and sizes, such as 50 g or 100 g glucose loads, and is intended for single use only during diagnostic testing procedures.

  • What regulatory pathway was used for the Glucose Tolerance Beverage?

    The device was cleared through the FDA 510(k) process as a substantially equivalent device under product code MRV and regulation number 862.1345.