The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Apolipoprotein A1.
| Device ID | K983289 |
| 510k Number | K983289 |
| Device Name: | APOLIPOPROTEIN A1 |
| Classification | Alpha-1-lipoprotein, Antigen, Antiserum, Control |
| Applicant | ABBOTT LABORATORIES DEPT. 09VA LC-2 1920 HURD DRIVE Irving, TX 75038 |
| Contact | Linda Morris |
| Correspondent | Linda Morris ABBOTT LABORATORIES DEPT. 09VA LC-2 1920 HURD DRIVE Irving, TX 75038 |
| Product Code | DER |
| CFR Regulation Number | 866.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-18 |
| Decision Date | 1999-01-29 |
| Summary: | summary |