Accuchek Bg.
510(k) K821091
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK821091 | Date14 May 1982 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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
The Accu-Chek Bg is a glucose oxidase, glucose device used for the quantitative measurement of glucose in blood. It is classified as a clinical chemistry device.
This device is authorized under FDA 510(k) clearance K821091. It is manufactured by Biodynamics Corp. and was cleared through the traditional 510(k) pathway.
Other devices from Biodynamics Corp.
Questions
AI-generated answers, 22 Sep 2026
What is the primary function of the Accu-Chek Bg?
The Accu-Chek Bg is a clinical chemistry device that utilizes glucose oxidase technology to provide quantitative measurements of glucose levels in blood samples.
How was this device authorized for use?
The Accu-Chek Bg was cleared by the FDA through the traditional 510(k) pathway under submission number K821091, which determined the device to be substantially equivalent to existing predicate devices.
Who is the manufacturer of the Accu-Chek Bg?
The device is manufactured by Biodynamics Corp., located in McHenry, Illinois.