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Chemstrip G

by Boehringer Mannheim Corp. 510(k)

Active United States

510(k) K770271

Overview

Chemstrip G is a method, enzymatic, glucose (urinary, non-quantitative) device used for clinical chemistry testing. It is designed to detect glucose in urine samples through an enzymatic reaction process.

The device is supplied by Boehringer Mannheim Corp. and is classified as Class II with special controls under regulation 862.1340. Chemstrip G is a single-use device and received FDA 510(k) clearance on March 16, 1977, with the K770271 product code.

AI-generated from registry data, 28 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK770271 Date16 Mar 1977ClearedStatusActive

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
JIL
Device Class
Class II
Regulation
21 CFR Part 862.1340
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is Chemstrip G used for?

    Chemstrip G is a method, enzymatic, glucose device used for clinical chemistry testing to detect glucose in urine samples through an enzymatic reaction process. It provides a non-quantitative measurement for clinical assessment.

  • Is Chemstrip G a single-use device?

    Yes, Chemstrip G is designed as a single-use device. Each strip should be used only once to ensure accurate test results and maintain hygiene standards in clinical settings.

  • What is the regulatory status of Chemstrip G?

    Chemstrip G received FDA 510(k) clearance on March 16, 1977, with product code JIL. It is classified as Class II with special controls under regulation 862.1340, making it substantially equivalent to other marketed devices.

  • How is Chemstrip G supplied?

    Chemstrip G is supplied by Boehringer Mannheim Corp. The device comes in a form that allows for easy handling and use in clinical chemistry testing, though specific packaging details are not provided in the available information.