Volumet CD4+ and CD8+ T Lymphocyte Count Test Kit
by Buckman Co., Inc. 510(k)
Active
510(k) K940003
Overview
The Volumet CD4+ and CD8+ T Lymphocyte Count Test Kit is a medical device used for counting CD4+ and CD8+ T lymphocytes. This device is classified as a counter and differential cell analyzer in the hematology field. It is designed to provide accurate counts of specific T lymphocyte subsets.
The test kit is manufactured by Buckman Co., Inc. and received FDA 510(k) clearance with number K940003 on October 19, 1995. It is a Class II device with product code GKZ. The device is supplied as a test kit for laboratory use in hematology applications.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK940003 | Date19 Oct 1995 | 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- Withdrawn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
- GKZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.5220
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Buckman Co., Inc.
Questions
What is the Volumet CD4+ and CD8+ T Lymphocyte Count Test Kit used for?
The Volumet CD4+ and CD8+ T Lymphocyte Count Test Kit is a medical device designed for laboratory use in hematology applications. It provides accurate counts of specific T lymphocyte subsets, including CD4+ and CD8+ cells, which are important for immune system assessment.
How is the Volumet CD4+ and CD8+ T Lymphocyte Count Test Kit supplied?
The device is supplied as a complete test kit for laboratory use. It includes all necessary components for counting CD4+ and CD8+ T lymphocytes, though specific kit contents are not detailed in the available information.
What is the regulatory status of the Volumet CD4+ and CD8+ T Lymphocyte Count Test Kit?
The test kit received FDA 510(k) clearance with number K940003 on October 19, 1995. It is classified as a Class II medical device with product code GKZ and is intended for laboratory use in hemology applications.
Is the Volumet CD4+ and CD8+ T Lymphocyte Count Test Kit reusable or single-use?
The available information does not specify whether the test kit is designed for single-use or multiple uses. As a laboratory test kit, it may contain components that are single-use while others could be reusable, depending on the specific protocol and components included.