EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay
FDA 510(k) K182353 · Phadia AB
510(k) numberK182353
Submission
- Device name
- EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay
- Applicant
- Phadia AB
Uppsala, SE - Received
- August 29, 2018
- Decision date
- November 27, 2018
- 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
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|---|---|---|---|
| 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 |
| K040953 | Aeskulisa Ana HEP-2LJM · Traditional | Aesku, Inc. | 06/23/2004SE |
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Questions and answers
When was EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay cleared by the FDA?
EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay (K182353) received a 510(k) decision of Substantially Equivalent on November 27, 2018, 90 days after the submission was received.
What is the product code of K182353?
The FDA product code is LJM – Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls, a Class II (moderate risk) device regulated under 21 CFR 866.5100.