# Lipogen, Inc.

- Location (FDA's records): Knoxville, TN
- FDA decisions: 15 (1987–1990): 15 510(k) clearances
- Product codes: LJM (5), LKP (2), LKO (2), LRY (1), LRM (1), LKJ (1), DHR (1), DHN (1), DHC (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K902636: Lipogen Rheumelisa Dsdna Assay (Jun 28, 1990)
- K895996: Rheumelisa Assay for SM Autoantibodies (Nov 6, 1989)
- K895997: Rheumelisa Assay for RNP Autoantibodies (Nov 6, 1989)
- K895995: Rheumelisa Assay for SS-B/LA Autoantibodies (Oct 27, 1989)
- K895994: Rheumelisa Assay for SS-a/RO Autoantibodies (Oct 24, 1989)
- K894659: Ana Antisera Control Kit (Sep 21, 1989)
- K892421: Modified Access R-Clone Ana/RF Screening Test (May 9, 1989)
- K885048: Access R-Clone Ana Profile Assay (Jan 24, 1989)

Source page: https://510kreport.com/company/lipogen