Modified Access R-Clone Ana/Rf Screening Test
FDA 510(k) K892421 · Lipogen, Inc.
510(k) numberK892421
Submission
- Device name
- Modified Access R-Clone Ana/Rf Screening Test
- Applicant
- Lipogen, Inc.
Knoxville, TN, US - Received
- April 10, 1989
- Decision date
- May 9, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LJM – Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5100
- Specialty
- Immunology
Other 510(k)s with product code LJM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K182353 | EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 ImmunoassayLJM · Traditional | Phadia AB | 11/27/2018SE |
| K151559 | ImmuLisa Enhanced Centromere Antibody ELISALJM · Traditional | Immco Diagnostics, Inc. | 03/11/2016SE |
| K140493 | Elia SCL-70S ImmunoassayLJM · Traditional | Phadia GmbH | 10/30/2014SE |
| K123880 | Quanta Flash CentromereLJM · Traditional | Inova Diagnostics, Inc. | 02/07/2014SE |
| K131330 | Gold Standard Diagnostics Anti-Nuclear Antibody (Ana) Screen Elisa Test KitLJM · Traditional | Gold Standard Diagnostics | 01/28/2014SE |
| K131185 | Ana Screen Elisa (Igg)LJM · Traditional | Euroimmun US | 07/15/2013SE |
| K083188 | Varelisa Recombi Ana Screen, Model 12 596LJM · Traditional | Phadia US, Inc. | 03/13/2009SE |
| K050967 | Varelisa Recombi CTD Screen, Model 13096LJM · Traditional | Sweden Diagnostics (Germany) GmbH | 06/28/2005SE |
| K050625 | Varelisa Recombi Ana Profile, Model 18496LJM · Traditional | Sweden Diagnostics (Germany) GmbH | 04/26/2005SE |
| K041102 | Immulisa Antinuclear Antibody Screen ElisaLJM · Traditional | Immco Diagnostics, Inc. | 10/26/2004SE |
More from Immco Diagnostics, Inc.
| 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 |
| 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 |
Questions and answers
When was Modified Access R-Clone Ana/Rf Screening Test cleared by the FDA?
Modified Access R-Clone Ana/Rf Screening Test (K892421) received a 510(k) decision of Substantially Equivalent on May 9, 1989, 29 days after the submission was received.
What is the product code of K892421?
The FDA product code is LJM – Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls, a Class II (moderate risk) device regulated under 21 CFR 866.5100.