The following data is part of a premarket notification filed by Lipogen, Inc. with the FDA for Ana Antisera Control Kit.
| Device ID | K894659 |
| 510k Number | K894659 |
| Device Name: | ANA ANTISERA CONTROL KIT |
| Classification | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | LIPOGEN, INC. 10515 RESEARCH DR. Knoxville, TN 37932 |
| Contact | Craig Dees |
| Correspondent | Craig Dees LIPOGEN, INC. 10515 RESEARCH DR. Knoxville, TN 37932 |
| Product Code | DHN |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-24 |
| Decision Date | 1989-09-21 |