CORA Coagulation Resonance Analysis System
510(k) K150041
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK150041 | Date26 Jun 2015 | 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- Withdrawn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, 1 Oct 2026
The CORA Coagulation Resonance Analysis System is a multipurpose in vitro diagnostic device designed for coagulation studies. It employs resonance analysis technology to assess blood coagulation parameters, including platelet function and clotting dynamics, using dried-in-place reagents within disposable cartridges. This automated system provides quantitative measurements to support hematological evaluations, particularly in diagnosing and monitoring coagulation disorders.
The device is intended for use in clinical laboratory settings and is supplied as a reusable analyzer with single-use cartridges. It has received FDA 510(k) clearance under the product code JPA, classified as a Class II device under special controls. The system operates with MRI-safe components and requires proper storage of cartridges in a dry, temperature-controlled environment to maintain sterility and performance. Authorizations include FDA clearance (K150041) and compliance with regulation 864.5425.
Other devices from Coramed Technologies, LLC
Questions
AI-generated answers, 1 Oct 2026
What is the CORA Coagulation Resonance Analysis System used for?
The CORA System is a multipurpose in vitro diagnostic device designed for coagulation studies. It employs resonance analysis technology to assess blood coagulation parameters, including platelet function and clotting dynamics, to support hematological evaluations in diagnosing and monitoring coagulation disorders.
How is the CORA System supplied and what are its components?
The CORA System is supplied as a reusable analyzer with single-use cartridges containing dried-in-place reagents. The cartridges are designed for one-time use to maintain sterility and performance, while the analyzer itself is a reusable device intended for clinical laboratory settings.
What are the storage requirements for the CORA System cartridges?
The cartridges must be stored in a dry, temperature-controlled environment to maintain sterility and performance. Proper storage conditions are essential to ensure the reliability of the coagulation measurements obtained when using the system.
What regulatory approvals does the CORA System have?
The CORA System has received FDA 510(k) clearance under product code JPA, classified as a Class II device under special controls. It is authorized with FDA clearance number K150041 and complies with regulation 864.5425.