Antithrombin Iii, Two Stage Clotting Time Assay
The Antithrombin III, Two Stage Clotting Time Assay is a hematology diagnostic device used to measure antithrombin III activity in plasma using a two-stage clotting time method, providing information on the natural anticoagulant capacity of blood and supporting the diagnosis of antithrombin III deficiency, which is associated with increased risk of venous thromboembolism. This device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification before marketing. It carries product code JPE and is regulated under 21 CFR 864.7060, within the Hematology medical specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- JPE
- Device Class
- FDA class 2
- Regulation Number
- 864.7060
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K933125 | BERICHROM ANTITHROMBIN III (A) | Apr 19, 1994 | Substantially Equivalent | Behring Diagnostics, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.