Control Plasma U
by Behring Diagnostics, Inc. 510(k)
Active
510(k) K924402
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK924402 | Date22 Feb 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- Withdrawn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
- GGC
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.5425
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
Control Plasma U is a hematology control plasma device used for quality control purposes in laboratory testing. It is classified as a Class II medical device under product code GGC, which covers control plasma and abnormal plasma products.
The device is supplied by Behring Diagnostics, Inc. and is intended for laboratory use. It received FDA 510(k) clearance on February 22, 1994, with K number K924402. The device is regulated under number 864.5425 and is registered with registration number 1721937.
Other devices from Behring Diagnostics, Inc.
Questions
AI-generated answers, 6 Oct 2026
What is the Control Plasma U device used for?
The Control Plasma U device is used for quality control purposes in laboratory testing, specifically in hematology.
Is the Control Plasma U device supplied sterile?
The device data does not specify if the Control Plasma U device is supplied sterile, it is intended for laboratory use.
What is the regulatory classification of the Control Plasma U device?
The Control Plasma U device is classified as a Class II medical device under product code GGC, which covers control plasma and abnormal plasma products.