Coag-A-Mate 2001
510(k) K790323
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK790323 | Date21 Mar 1979 | 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- Withdrawn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, 27 Sep 2026
The Coag-A-Mate 2001 is a system for in vitro coagulation studies, designed for determining prothrombin times, activated partial thromboplastin times, and other related tests. It is a photo-optical clot detection system for in vitro diagnostic use.
The Coag-A-Mate 2001 is supplied with an Operator's Manual and is classified as a device with a product code of JPA. It has been cleared with FDA 510K number K790323 and is regulated under regulation number 864.5425. The device is intended for use in hematology and is designed for in vitro diagnostic use.
Other devices from General Diagnostics
Questions
AI-generated answers, 27 Sep 2026
What is the Coag-A-Mate 2001 used for?
The Coag-A-Mate 2001 is used for in vitro coagulation studies, including determining prothrombin times, activated partial thromboplastin times, and other related tests.
Is the Coag-A-Mate 2001 supplied with any additional materials?
Yes, the Coag-A-Mate 2001 is supplied with an Operator's Manual.
What is the regulatory classification of the Coag-A-Mate 2001?
The Coag-A-Mate 2001 is regulated under regulation number 864.5425 and has been cleared with FDA 510K number K790323.