Stratus CS Troponin I Calibrator
by Dade Behring, Inc. 510(k)
Active
510(k) K983722
Overview
The Stratus CS Troponin I Calibrator is a clinical chemistry device used to calibrate the cardiac troponin I method on the Stratus CS analyzer. It serves as a calibrator for diagnostic testing procedures.
This device is supplied by Dade Behring, Inc. and has received FDA 510(k) clearance. It is classified as a Class 2 device under the clinical chemistry advisory committee.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK983722 | Date4 Nov 1998 | 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- Withdrawn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
- JIT
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1150
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Dade Behring, Inc.
Questions
What is the primary purpose of the Stratus CS Troponin I Calibrator?
This device is used to calibrate the cardiac troponin I testing method specifically for the Stratus CS analyzer. It ensures that the diagnostic testing procedures performed on the analyzer remain accurate.
What is the regulatory classification of this device?
The Stratus CS Troponin I Calibrator is classified as a Class 2 device under the clinical chemistry advisory committee and has received FDA 510(k) clearance.
Who is the manufacturer of this calibrator?
This device is supplied and manufactured by Dade Behring, Inc., located in Newark, Delaware.