The following data is part of a premarket notification filed by Crestat Diagnostics, Inc. with the FDA for N-assay Tia Apo B Test Kit.
| Device ID | K964296 |
| 510k Number | K964296 |
| Device Name: | N-ASSAY TIA APO B TEST KIT |
| Classification | Alpha-1-lipoprotein, Antigen, Antiserum, Control |
| Applicant | CRESTAT DIAGNOSTICS, INC. 25549 ADAMS AVE. Murrieta, CA 92562 |
| Product Code | DER |
| CFR Regulation Number | 866.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-29 |
| Decision Date | 1997-08-01 |