Coamate Antithrombin Chromogenic Assay
510(k) K915083
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK915083 | Date3 Jan 1992 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Coamate(R) Antithrombin Chromogenic Assay
- 510(k) Number
- FDA Product Code
- JBQ
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.7060
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
The Coamate Antithrombin Chromogenic Assay is an in vitro diagnostic device used for the quantitation of antithrombin III. It is classified as an antithrombin III quantitation test intended for clinical laboratory use.
This device has received FDA 510(k) clearance under K915083. It is categorized under the hematology medical specialty and is regulated under 21 CFR 864.7060.
Other devices from Pharmacia Hepar, Inc.
Questions
AI-generated answers, 22 Sep 2026
What is the primary clinical use of the Coamate Antithrombin Chromogenic Assay?
This device is intended for use in clinical laboratories to perform the quantitation of antithrombin III, a protein that helps regulate blood clotting.
What is the regulatory status of this device?
The Coamate Antithrombin Chromogenic Assay has received FDA 510(k) clearance under K915083, confirming it is substantially equivalent to predicate devices for its intended use.
Under which medical specialty is this assay categorized?
This device is categorized under the hematology medical specialty and is regulated under 21 CFR 864.7060, which pertains to antithrombin III quantitation tests.