The following data is part of a premarket notification filed by Crestat Diagnostics, Inc. with the FDA for N-assay Tia Antithrombin Iii Test Kit.
| Device ID | K972257 |
| 510k Number | K972257 |
| Device Name: | N-ASSAY TIA ANTITHROMBIN III TEST KIT |
| Classification | Antigen, Antiserum, Control, Antithrombin Iii |
| Applicant | CRESTAT DIAGNOSTICS, INC. 374 GOODHILL RD. Weston, CT 06883 |
| Contact | Mary Rees |
| Correspondent | Mary Rees CRESTAT DIAGNOSTICS, INC. 374 GOODHILL RD. Weston, CT 06883 |
| Product Code | DDQ |
| CFR Regulation Number | 864.7060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-17 |
| Decision Date | 1997-10-20 |