ImmuLisa Enhanced Centromere Antibody ELISA
FDA 510(k) K151559 · Immco Diagnostics, Inc.
510(k) numberK151559
Submission
- Device name
- ImmuLisa Enhanced Centromere Antibody ELISA
- Applicant
- Immco Diagnostics, Inc.
Buffalo, NY, US - Received
- June 10, 2015
- Decision date
- March 11, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K040953 | Aeskulisa Ana HEP-2LJM · Traditional | Aesku, Inc. | 06/23/2004SE |
More from Aesku, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K172745 | ImmuGlo HEp-2 Elite IFADHN · Traditional | 06/05/2018SE |
| K172078 | ImmuLisa Enhanced RNA POL III Antibody ELISANYO · Traditional | 03/30/2018SE |
| K163133 | ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISADBM · Traditional | 08/08/2017SE |
| K163177 | ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISAMST · Traditional | 07/28/2017SE |
| K162788 | ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA…MSV · Traditional | 06/19/2017SE |
| K143736 | ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA…DHR · Traditional | 09/23/2015SE |
| K142781 | ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA…LLL · Traditional | 03/31/2015SE |
| K123713 | Immulisa Enhanced Celiac Fusion (Ttg/Dgp) Iga/Igg Antibody ElisaMVM · Traditional | 10/25/2013SE |
| K113020 | Immulisa Enhanced (TM) Cardiolipin Iga, Igg, Igm and Iga/Igg/Igm Antibody (Aca) ElisasMID · Traditional | 10/25/2012SE |
| K113143 | Immulisa SCI-70 Antibody ElisaLLL · Traditional | 12/02/2011SE |
Questions and answers
When was ImmuLisa Enhanced Centromere Antibody ELISA cleared by the FDA?
ImmuLisa Enhanced Centromere Antibody ELISA (K151559) received a 510(k) decision of Substantially Equivalent on March 11, 2016, 275 days after the submission was received.
What is the product code of K151559?
The FDA product code is LJM – Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls, a Class II (moderate risk) device regulated under 21 CFR 866.5100.