The following data is part of a premarket notification filed by Lipogen, Inc. with the FDA for Access R-clone(tm) Ana/rf Screening Assay.
| Device ID | K882740 |
| 510k Number | K882740 |
| Device Name: | ACCESS R-CLONE(TM) ANA/RF SCREENING ASSAY |
| Classification | Antinuclear Antibody, Antigen, 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 | LKJ |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-01 |
| Decision Date | 1988-09-22 |