GFT · Protamine Sulphate
Hematology · 21 CFR 864.7525 · Class 2
Overview
| Product Code | GFT |
|---|---|
| Device Name | Protamine Sulphate |
| Regulation | 21 CFR 864.7525 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
Identification
A heparin assay is a device used to determine the level of the anticoagulant heparin in the patient's circulation. These assays are quantitative clotting time procedures using the effect of heparin on activated coagulation factor X (Stuart factor) or procedures based on the neutralization of heparin by protamine sulfate (a protein that neutralizes heparin).
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K944115 | HEPARIN ASSAY CARTRIDGES AND CONTROLS | Medtronic Hemotec, Inc. | Mar 24, 1995 | SESE |
| K910105 | PROTAMINE RESPONSE TEST CATALOGUE NUMBER PRT 200 | International Technidyne Corp. | Feb 26, 1991 | SESE |
Top Applicants
- International Technidyne Corp. — 1 clearance
- Medtronic Hemotec, Inc. — 1 clearance
