Amicon Ultrafiltration Membranes CMII
by Amicon, Inc.
510(k) K810810
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK810810 | Date17 Apr 1981 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DHX
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.6010
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
The Amicon Ultrafiltration Membranes CMII are designed for ultrafiltration processes. These membranes facilitate the concentration of proteins and other biomolecules from various sample matrices.
This device is identified under FDA 510(k) clearance K810810. It is manufactured by Amicon, Inc. and is categorized under the immunology medical specialty.
Other devices from Amicon, Inc.
Questions
AI-generated answers, 6 Oct 2026
What is the primary function of the Amicon Ultrafiltration Membranes CMII?
The Amicon Ultrafiltration Membranes CMII are specialized membranes engineered to facilitate the concentration of proteins and other biomolecules from a variety of sample matrices during ultrafiltration processes.
What is the regulatory status of this device?
This device is identified under FDA 510(k) clearance number K810810, which was granted following a traditional submission process and a determination of substantial equivalence.
In which medical specialty are these membranes categorized?
The Amicon Ultrafiltration Membranes CMII are categorized under the immunology medical specialty and are associated with product code DHX and regulation number 866.6010.