Skip to content

Glucose (Trinder) Reagent

by Gilford Diagnostics 510(k)

Active United States

510(k) K801600

Overview

For the GLUCOSE (TRINDER) REAGENT, a widely used clinical chemistry reagent for measuring glucose levels. As a substantially equivalent device to others in its class, it is approved for use in a variety of medical settings.

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK801600 Date27 Aug 1980ClearedStatusActive

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  • Withdrawn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
CGA
Device Class
Class II
Regulation
21 CFR Part 862.1345
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Other devices from Gilford Diagnostics

See all devices from Gilford Diagnostics →