The following data is part of a premarket notification filed by Crestat Diagnostics, Inc. with the FDA for N-assay Tia C1-inactivator Test Kit.
| Device ID | K965024 |
| 510k Number | K965024 |
| Device Name: | N-ASSAY TIA C1-INACTIVATOR TEST KIT |
| Classification | Complement C1 Inhibitor (inactivator), Antigen, Antiserum, Control |
| 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 | DBA |
| CFR Regulation Number | 866.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-17 |
| Decision Date | 1997-07-14 |