Lipogen, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Lipogen, Inc.” (first 1987, latest 1990), across 9 product codes in 2 review panels. Median 510(k) review time under this name: 50 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 5 | 5 |
| LKO | Anti-Rnp Antibody, Antigen And Control | 2 | 2 |
| LKP | Anti-Sm Antibody, Antigen And Control | 2 | 2 |
| DHC | System, Test, Systemic Lupus Erythematosus | 1 | 1 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 1 | 1 |
| DHR | System, Test, Rheumatoid Factor | 1 | 1 |
| LKJ | Antinuclear Antibody, Antigen, Control | 1 | 1 |
| LRM | Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | 1 | 1 |
| LRY | Punch, Surgical | 1 | 1 |
Review panels
Most recent Lipogen, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K902636 | LIPOGEN RHEUMELISA DSDNA ASSAY | LRY | 1990-06-28 | 14 |
| K895997 | RHEUMELISA ASSAY FOR RNP AUTOANTIBODIES | LKO | 1989-11-06 | 24 |
| K895996 | RHEUMELISA ASSAY FOR SM AUTOANTIBODIES | LKP | 1989-11-06 | 24 |
| K895995 | RHEUMELISA ASSAY FOR SS-B/LA AUTOANTIBODIES | LJM | 1989-10-27 | 14 |
| K895994 | RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIES | LJM | 1989-10-24 | 11 |
| K894659 | ANA ANTISERA CONTROL KIT | DHN | 1989-09-21 | 59 |
| K892421 | MODIFIED ACCESS R-CLONE ANA/RF SCREENING TEST | LJM | 1989-05-09 | 29 |
| K885048 | ACCESS R-CLONE ANA PROFILE ASSAY | DHC | 1989-01-24 | 48 |
| K882740 | ACCESS R-CLONE(TM) ANA/RF SCREENING ASSAY | LKJ | 1988-09-22 | 83 |
| K880254 | SM ANTIBODY TEST KIT | LKP | 1988-04-06 | 77 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Lipogen, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Lipogen, Inc.?
FDA lists 15 510(k) clearances under the applicant name “Lipogen, Inc.” (first 1987, latest 1990), across 9 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Lipogen, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lipogen, Inc. is 50 days.
Which FDA product codes appear under Lipogen, Inc.?
The most frequent FDA product codes under this applicant name are LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls, 5); LKO (Anti-Rnp Antibody, Antigen And Control, 2); LKP (Anti-Sm Antibody, Antigen And Control, 2).
Next steps
- See all 15 Lipogen, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LJM, Lipogen, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.