Lipogen, Inc.
Knoxville, TN, US
Lipogen, Inc. appears in FDA device records in Knoxville, TN. FDA records list 15 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 15
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 15 510(k) clearances for Lipogen, Inc. between 1987 and 1990. The busiest year on record is 1989, with 7. The most recent is 1990, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1987 | 2 |
| 1988 | 5 |
| 1989 | 7 |
| 1990 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K902636 | LIPOGEN RHEUMELISA DSDNA ASSAY | LRY | Substantially Equivalent | |
| K895997 | RHEUMELISA ASSAY FOR RNP AUTOANTIBODIES | LKO | Substantially Equivalent | |
| K895996 | RHEUMELISA ASSAY FOR SM AUTOANTIBODIES | LKP | Substantially Equivalent | |
| K895995 | RHEUMELISA ASSAY FOR SS-B/LA AUTOANTIBODIES | LJM | Substantially Equivalent | |
| K895994 | RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIES | LJM | Substantially Equivalent | |
| K894659 | ANA ANTISERA CONTROL KIT | DHN | Substantially Equivalent | |
| K892421 | MODIFIED ACCESS R-CLONE ANA/RF SCREENING TEST | LJM | Substantially Equivalent | |
| K885048 | ACCESS R-CLONE ANA PROFILE ASSAY | DHC | Substantially Equivalent | |
| K882740 | ACCESS R-CLONE(TM) ANA/RF SCREENING ASSAY | LKJ | Substantially Equivalent | |
| K880254 | SM ANTIBODY TEST KIT | LKP | Substantially Equivalent | |
| K874195 | LA ANTIBODY TEST KIT | LJM | Substantially Equivalent | |
| K874152 | RNP ANTIBODY TEST KIT | LKO | Substantially Equivalent | |
| K875246 | LIPOGEN ANA TEST KIT | LJM | Substantially Equivalent | |
| K874151 | RF DIPSTICK TEST KIT | DHR | Substantially Equivalent | |
| K874191 | NDNA ANTIBODY TEST KIT | LRM | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- LRMAnti-Dna Antibody (Enzyme-Labeled), Antigen, Control
- LKOAnti-Rnp Antibody, Antigen And Control
- LKPAnti-Sm Antibody, Antigen And Control
- LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, Controls
- LKJAntinuclear Antibody, Antigen, Control
- DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
- LRYPunch, Surgical
- DHRSystem, Test, Rheumatoid Factor
- DHCSystem, Test, Systemic Lupus Erythematosus
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain