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Glucose Tolerance Beverage

by Perk Scientific, Inc.

510(k) K032753

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 NumberK032753 Date18 Nov 2003ClearedStatusActive

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  • Withdrawn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
MRV
Device Class
Class II
Regulation
21 CFR Part 862.1345
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.

Glucose Tolerance Beverage is a water-based, flavored beverage containing specific quantities of dextrose. It serves as an accessory to In Vitro Diagnostic Glucose Tolerance Tests.

Patients consume the beverage as part of glucose tolerance testing procedures. The device is supplied by Perk Scientific, Inc. and is authorized under FDA 510K K032753 as a Class II medical device with product code MRV.

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 Glucose Tolerance Beverage used for?

    The Glucose Tolerance Beverage is a water-based, flavored beverage containing specific quantities of dextrose. It serves as an accessory to In Vitro Diagnostic Glucose Tolerance Tests, consumed by patients as part of testing procedures.

  • How is the Glucose Tolerance Beverage supplied?

    The beverage is supplied by Perk Scientific, Inc. It is authorized under FDA 510K K032753 as a Class II medical device with product code MRV, designed specifically for use in glucose tolerance testing.

  • Is the Glucose Tolerance Beverage sterile and single-use?

    The device is supplied as a ready-to-consume beverage for single use in glucose tolerance testing procedures. Each container is intended for one patient use to ensure accurate test results and maintain testing integrity.

  • What are the regulatory requirements for this product?

    The Glucose Tolerance Beverage is authorized under FDA 510K K032753 as a Class II medical device with product code MRV. It received clearance through the traditional review process by the Clinical Chemistry advisory committee in 2003.