Sysmex Automated Blood Coagulation Analyzer CS-5100
by Siemens Healthcare Diagnostic Products GmbH
510(k) K150678
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK150678 | Date11 Jan 2016 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JPA
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.5425
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
The Sysmex Automated Blood Coagulation Analyzer CS-5100 is a multipurpose system designed for in vitro coagulation studies. It functions as a random-access, high-volume analyzer that performs simultaneous multiwavelength analysis to support diagnostic testing.
This device is regulated under FDA 510(k) clearance as a Class 2 medical device. It is intended for use in laboratory settings to manage and analyze blood specimens for coagulation assessment.
Other devices from Siemens Healthcare Diagnostic Products GmbH
Questions
AI-generated answers, 22 Sep 2026
What is the primary function of the Sysmex CS-5100?
The Sysmex CS-5100 is a multipurpose system designed for in vitro coagulation studies. It functions as a random-access, high-volume analyzer that performs simultaneous multiwavelength analysis to support diagnostic testing in laboratory settings.
What is the regulatory status of this analyzer?
This device is regulated under FDA 510(k) clearance as a Class 2 medical device. It was determined to be substantially equivalent to existing devices for its intended use in managing and analyzing blood specimens for coagulation assessment.
In what environment is this device intended to be used?
The Sysmex CS-5100 is intended for use in professional laboratory settings. It is designed to handle high-volume workloads, making it suitable for clinical environments that require efficient and simultaneous multiwavelength analysis of blood specimens.