Company ยท US
Lipogen, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1987 to 1990. Name variants (Inc, Corp, punctuation) are merged.
15510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 5 |
| LKO | Anti-Rnp Antibody, Antigen And Control | 2 |
| LKP | Anti-Sm Antibody, Antigen And Control | 2 |
| DHC | System, Test, Systemic Lupus Erythematosus | 1 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 1 |
| DHR | System, Test, Rheumatoid Factor | 1 |
| LKJ | Antinuclear Antibody, Antigen, Control | 1 |
| LRM | Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | 1 |
| LRY | Punch, Surgical | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 28, 1990 | K902636 | LIPOGEN RHEUMELISA DSDNA ASSAY Lipogen, Inc. | LRY |
| Nov 6, 1989 | K895997 | RHEUMELISA ASSAY FOR RNP AUTOANTIBODIES Lipogen, Inc. | LKO |
| Nov 6, 1989 | K895996 | RHEUMELISA ASSAY FOR SM AUTOANTIBODIES Lipogen, Inc. | LKP |
| Oct 27, 1989 | K895995 | RHEUMELISA ASSAY FOR SS-B/LA AUTOANTIBODIES Lipogen, Inc. | LJM |
| Oct 24, 1989 | K895994 | RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIES Lipogen, Inc. | LJM |
| Sep 21, 1989 | K894659 | ANA ANTISERA CONTROL KIT Lipogen, Inc. | DHN |
| May 9, 1989 | K892421 | MODIFIED ACCESS R-CLONE ANA/RF SCREENING TEST Lipogen, Inc. | LJM |
| Jan 24, 1989 | K885048 | ACCESS R-CLONE ANA PROFILE ASSAY Lipogen, Inc. | DHC |
| Sep 22, 1988 | K882740 | ACCESS R-CLONE(TM) ANA/RF SCREENING ASSAY Lipogen, Inc. | LKJ |
| Apr 6, 1988 | K880254 | SM ANTIBODY TEST KIT Lipogen, Inc. | LKP |
| Mar 11, 1988 | K874195 | LA ANTIBODY TEST KIT Lipogen, Inc. | LJM |
| Mar 11, 1988 | K874152 | RNP ANTIBODY TEST KIT Lipogen, Inc. | LKO |
| Feb 10, 1988 | K875246 | LIPOGEN ANA TEST KIT Lipogen, Inc. | LJM |
| Dec 29, 1987 | K874151 | RF DIPSTICK TEST KIT Lipogen, Inc. | DHR |
| Dec 18, 1987 | K874191 | NDNA ANTIBODY TEST KIT Lipogen, Inc. | LRM |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||