Glucofilm Test Strips
by Heraeus Kulzer, Inc. 510(k)
Active
510(k) K936212
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK936212 | Date10 May 1994 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
- CGA
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1345
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
Glucofilm Test Strips are medical devices classified as Glucose Oxidase, Glucose. These test strips are designed for use in clinical chemistry applications to measure glucose levels.
The device is supplied by Heraeus Kulzer, Inc. and is a Class II medical device with special controls. It received FDA 510(k) clearance on May 10, 1994, with the product code CGA. The device is intended for single-use and should be stored according to the manufacturer's instructions.
Other devices from Heraeus Kulzer, Inc.
Questions
AI-generated answers, 22 Sep 2026
What are Glucofilm Test Strips used for?
Glucofilm Test Strips are medical devices designed for clinical chemistry applications to measure glucose levels. They utilize glucose oxidase technology to provide accurate glucose measurements in laboratory settings.
How are Glucofilm Test Strips supplied and what is their sterility status?
Glucofilm Test Strips are supplied by Heraeus Kulzer, Inc. as single-use devices. They are packaged to maintain sterility until opened for use, as required for Class II medical devices with special controls.
What is the regulatory status of Glucofilm Test Strips?
Glucofilm Test Strips received FDA 510(k) clearance on May 10, 1994, with product code CGA. They are classified as Class II medical devices with special controls, indicating they meet specific regulatory requirements for safety and effectiveness.
How should Glucofilm Test Strips be stored?
Glucofilm Test Strips should be stored according to the manufacturer's instructions to maintain their integrity and accuracy. Proper storage conditions are essential to ensure the device functions as intended for measuring glucose levels.