The following data is part of a premarket notification filed by Lipogen, Inc. with the FDA for Sm Antibody Test Kit.
| Device ID | K880254 |
| 510k Number | K880254 |
| Device Name: | SM ANTIBODY TEST KIT |
| Classification | Anti-sm Antibody, Antigen And Control |
| Applicant | LIPOGEN, INC. 10515 RESEARCH DR. Knoxville, TN 37932 |
| Contact | W Fountain |
| Correspondent | W Fountain LIPOGEN, INC. 10515 RESEARCH DR. Knoxville, TN 37932 |
| Product Code | LKP |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-20 |
| Decision Date | 1988-04-06 |