Lipogen, Inc.
Medical device manufacturer in Knoxville, TN.
15510(k) clearances
0PMA approvals
0recalls
Device types
- LJM Antinuclear Antibody (Enzyme-Labeled)… 5
- LKO Anti-Rnp Antibody, Antigen And Control 2
- LKP Anti-Sm Antibody, Antigen And Control 2
- LRM Anti-Dna Antibody (Enzyme-Labeled)… 1
- DHR System, Test, Rheumatoid Factor 1
- LKJ Antinuclear Antibody, Antigen, Control 1
- DHC System, Test, Systemic Lupus Erythematosus 1
- DHN Antinuclear Antibody, Indirect… 1
- LRY Punch, Surgical 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K902636 | Lipogen Rheumelisa Dsdna AssayLRY · Traditional | 06/28/1990SE |
| K895997 | Rheumelisa Assay for RNP AutoantibodiesLKO · Traditional | 11/06/1989SE |
| K895996 | Rheumelisa Assay for SM AutoantibodiesLKP · Traditional | 11/06/1989SE |
| K895995 | Rheumelisa Assay for Ss-B/La AutoantibodiesLJM · Traditional | 10/27/1989SE |
| K895994 | Rheumelisa Assay for Ss-A/Ro AutoantibodiesLJM · Traditional | 10/24/1989SE |
| K894659 | Ana Antisera Control KitDHN · Traditional | 09/21/1989SE |
| K892421 | Modified Access R-Clone Ana/Rf Screening TestLJM · Traditional | 05/09/1989SE |
| K885048 | Access R-Clone Ana Profile AssayDHC · Traditional | 01/24/1989SE |
| K882740 | Access R-Clone(Tm) Ana/Rf Screening AssayLKJ · Traditional | 09/22/1988SE |
| K880254 | SM Antibody Test KitLKP · Traditional | 04/06/1988SE |
| K874195 | La Antibody Test KitLJM · Traditional | 03/11/1988SE |
| K874152 | RNP Antibody Test KitLKO · Traditional | 03/11/1988SE |
| K875246 | Lipogen Ana Test KitLJM · Traditional | 02/10/1988SE |
| K874151 | RF Dipstick Test KitDHR · Traditional | 12/29/1987SE |
| K874191 | Ndna Antibody Test KitLRM · Traditional | 12/18/1987SE |