Autozyme
by Cambridge Life Sciences Plc.
510(k) K922241
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK922241 | Date30 Nov 1992 | 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- Withdrawn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
- LLL
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.5100
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
The Autozyme is an extractable antinuclear antibody, antigen and control device, classified as a class 2 device. It is used in the field of immunology. The device is substantially equivalent and has a product code of LLL.
The Autozyme is supplied with essential components and is used for the diagnosis and monitoring of autoimmune diseases. It has FDA 510K authorization and is regulated under regulation number 866.5100. The device is developed and manufactured by Cambridge Life Sciences Plc.
Other devices from Cambridge Life Sciences Plc.
Questions
AI-generated answers, 22 Sep 2026
What is the Autozyme device used for?
The Autozyme is used for the diagnosis and monitoring of autoimmune diseases, specifically in the field of immunology.
Is the Autozyme device supplied with essential components?
Yes, the Autozyme is supplied with essential components, making it a complete solution for diagnosing autoimmune diseases.
What is the regulatory classification of the Autozyme device?
The Autozyme is classified as a class 2 device, with a product code of LLL and regulation number 866.5100.
Who manufactures the Autozyme device?
The Autozyme is developed and manufactured by Cambridge Life Sciences Plc.