The following data is part of a premarket notification filed by Lipogen, Inc. with the FDA for Lipogen Rheumelisa Dsdna Assay.
| Device ID | K902636 |
| 510k Number | K902636 |
| Device Name: | LIPOGEN RHEUMELISA DSDNA ASSAY |
| Classification | Punch, Surgical |
| Applicant | LIPOGEN, INC. 10515 RESEARCH DR. Knoxville, TN 37932 |
| Contact | Mokros, M.s. |
| Correspondent | Mokros, M.s. LIPOGEN, INC. 10515 RESEARCH DR. Knoxville, TN 37932 |
| Product Code | LRY |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-14 |
| Decision Date | 1990-06-28 |