The following data is part of a premarket notification filed by Lipogen, Inc. with the FDA for Rnp Antibody Test Kit.
| Device ID | K874152 |
| 510k Number | K874152 |
| Device Name: | RNP ANTIBODY TEST KIT |
| Classification | Anti-rnp Antibody, Antigen And Control |
| Applicant | LIPOGEN, INC. 10515 RESEARCH DR. Knoxville, TN 37932 |
| Contact | Michael Fountain,phd |
| Correspondent | Michael Fountain,phd LIPOGEN, INC. 10515 RESEARCH DR. Knoxville, TN 37932 |
| Product Code | LKO |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-13 |
| Decision Date | 1988-03-11 |