11-Dehydro Thromboxane B2 Kit, Urinary
FDA product code OBW · Class II (moderate risk) · 21 CFR 864.5700 · Hematology
The test kit is an enzyme-linked immunoassay (elisa) to determine levels of 11-dehydro thromboxane b2 (11dhtxb2) in human urine, which aids in the qualitative detection of aspirin effect in apparently healthy individuals post ingestion. For professional use only.
1510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K062025 | Aspirinworks Test Kit (11-DEHYDRO Thromboxane B2), Model 12136OBW · Traditional | Corgenix, Inc. | 05/29/2007SE |