The following data is part of a premarket notification filed by Lipogen, Inc. with the FDA for Access R-clone Ana Profile Assay.
| Device ID | K885048 |
| 510k Number | K885048 |
| Device Name: | ACCESS R-CLONE ANA PROFILE ASSAY |
| Classification | System, Test, Systemic Lupus Erythematosus |
| Applicant | LIPOGEN, INC. 10515 RESEARCH DR. Knoxville, TN 37932 |
| Contact | Dees, Ph.d. |
| Correspondent | Dees, Ph.d. LIPOGEN, INC. 10515 RESEARCH DR. Knoxville, TN 37932 |
| Product Code | DHC |
| CFR Regulation Number | 866.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-07 |
| Decision Date | 1989-01-24 |