The following data is part of a premarket notification filed by Lipogen, Inc. with the FDA for Rheumelisa Assay For Ss-a/ro Autoantibodies.
| Device ID | K895994 |
| 510k Number | K895994 |
| Device Name: | RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIES |
| Classification | Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
| Applicant | LIPOGEN, INC. 10515 RESEARCH DR. Knoxville, TN 37932 |
| Contact | Dees, Phd |
| Correspondent | Dees, Phd LIPOGEN, INC. 10515 RESEARCH DR. Knoxville, TN 37932 |
| Product Code | LJM |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-13 |
| Decision Date | 1989-10-24 |