Olympus Glucose Reagent
by Olympus Corp. 510(k)
Active
510(k) K924601
Overview
The Olympus Glucose Reagent is a glucose test system intended to measure glucose quantitatively in blood and other body fluids. It is classified as a Hexokinase, Glucose device under product code CFR.
This device is authorized by the FDA with 510(k) clearance K924601, issued on December 3, 1992. It is a Class II device under special controls. The reagent is manufactured by Olympus Corp. in Lake Success, NY.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK924601 | Date3 Dec 1992 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- CFR
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1345
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Olympus Corp.
Questions
What is the Olympus Glucose Reagent used for?
The Olympus Glucose Reagent is a test system designed to measure glucose quantitatively in blood and other body fluids. It is classified as a Hexokinase, Glucose device under product code CFR.
What is the regulatory status of this device?
The Olympus Glucose Reagent is authorized by the FDA with 510(k) clearance K924601, issued on December 3, 1992. It is classified as a Class II device under special controls.
Who manufactures the Olympus Glucose Reagent and where is it produced?
The Olympus Glucose Reagent is manufactured by Olympus Corp. in Lake Success, NY. The company has been producing this device since it received FDA clearance in 1992.
What is the product classification of this glucose testing system?
The Olympus Glucose Reagent is classified under product code CFR as a Hexokinase, Glucose device. It falls under the Clinical Chemistry advisory committee with review code CH.