The following data is part of a premarket notification filed by Ventrex Laboratories, Inc. with the FDA for Ventria Apo A-1 Alpha-1 Lipotrotein.
| Device ID | K840830 |
| 510k Number | K840830 |
| Device Name: | VENTRIA APO A-1 ALPHA-1 LIPOTROTEIN |
| Classification | Alpha-1-lipoprotein, Antigen, Antiserum, Control |
| Applicant | VENTREX LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DER |
| CFR Regulation Number | 866.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-24 |
| Decision Date | 1984-05-21 |