The following data is part of a premarket notification filed by Baxter Diagnostics, Inc. with the FDA for Dade(r) Thrombin-antithrombin (tat) Complex Elisa.
| Device ID | K935307 |
| 510k Number | K935307 |
| Device Name: | DADE(R) THROMBIN-ANTITHROMBIN (TAT) COMPLEX ELISA |
| Classification | Antigen, Antiserum, Control, Antithrombin Iii |
| Applicant | BAXTER DIAGNOSTICS, INC. P.O. BOX 520672 Miami, FL 33152 |
| Contact | Radames Riesgo |
| Correspondent | Radames Riesgo BAXTER DIAGNOSTICS, INC. P.O. BOX 520672 Miami, FL 33152 |
| Product Code | DDQ |
| CFR Regulation Number | 864.7060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-02 |
| Decision Date | 1994-11-22 |