Control Plasma N
by Dade Behring, Inc. 510(k)
Active
510(k) K023309
Overview
This device is a plasma control, normal, intended for use with a multipurpose system for in vitro coagulation studies. It is classified as Plasma, Control, Normal under product code GIZ and falls within the hematology medical specialty.
The device is supplied as a control for laboratory use in coagulation testing. It received FDA 510(k) clearance (K023309) on November 1, 2002, and is classified as a Class II device subject to special controls. It is not sterile, not implantable, and not intended for direct patient contact.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK023309 | Date1 Nov 2002 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- GIZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.5425
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Dade Behring, Inc.
Questions
What is the CONTROL PLASMA N device used for?
The CONTROL PLASMA N is a normal plasma control intended for use with a multipurpose system to perform in vitro coagulation studies, helping ensure test accuracy and reliability in hematology laboratories.
How is the CONTROL PLASMA N supplied and is it sterile?
The device is supplied as a liquid plasma control for laboratory use in coagulation testing and is not sterile, as it is intended for in vitro diagnostic use only and does not require sterility.
Can the CONTROL PLASMA N be reused or is it single-use?
The CONTROL PLASMA N is intended for single-use in quality control procedures; reuse is not recommended as it may compromise test integrity and is not supported by the manufacturer’s labeling or clearance.
What regulatory pathway was used for the CONTROL PLASMA N?
The device received FDA 510(k) clearance under submission K023309 on November 1, 2002, demonstrating substantial equivalence to a legally marketed predicate device.
Is the CONTROL PLASMA N intended for direct patient contact or implantation?
No, the CONTROL PLASMA N is not intended for direct patient contact or implantation; it is strictly an in vitro diagnostic control for use in laboratory coagulation testing only.