OBW · 11-Dehydro Thromboxane B2 Kit, Urinary
Hematology · 21 CFR 864.5700 · Class 2
Overview
| Product Code | OBW |
|---|---|
| Device Name | 11-Dehydro Thromboxane B2 Kit, Urinary |
| Regulation | 21 CFR 864.5700 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
Identification
An automated platelet aggregation system is a device used to determine changes in platelet shape and platelet aggregation following the addition of an aggregating reagent to a platelet-rich plasma.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K062025 | ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136 | Corgenix, Inc. | May 29, 2007 | SESE |
Top Applicants
- Corgenix, Inc. — 1 clearance
