Antigen, Antiserum, Control, Antithrombin Iii
FDA product code DDQ · Class II (moderate risk) · 21 CFR 864.7060 · Hematology
4510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972257 | N-Assay Tia Antithrombin III Test KitDDQ · Traditional | Crestat Diagnostics, Inc. | 10/20/1997SE |
| K935307 | Dade(R) Thrombin-Antithrombin (Tat) Complex ElisaDDQ · Traditional | Baxter Diagnostics, Inc. | 11/22/1994SE |
| K932713 | Trace Transferrin ReagentDDQ · Traditional | Trace Scientific , Ltd. | 09/30/1993SE |
| K780012 | Antithrombin III RiaDDQ · Traditional | Ria Diagnostics | 01/20/1978SE |