Seraquest Anti-Ssa
FDA 510(k) K980810 · Quest Intl., Inc.
510(k) numberK980810
Submission
- Device name
- Seraquest Anti-Ssa
- Applicant
- Quest Intl., Inc.
North Miami, FL, US - Received
- March 3, 1998
- Decision date
- May 12, 1998
- 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 |
| 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 |
|---|---|---|
| K091260 | Seraquest Ebv Ea-D Igg TestLSE · Traditional | 06/08/2009SE |
| K033915 | Modification to Seraquest Eb Vca IggLSE · Special | 01/16/2004SE |
| K033780 | Modification to Seraquest Vca IgmLJN · Special | 01/15/2004SE |
| K023593 | Seraquest Anti-Thyroid Peroxidase (Tpo)JZO · Traditional | 02/06/2003SE |
| K023592 | Seraquest Anti-ThyroglobulinDDC · Traditional | 01/06/2003SE |
| K003069 | Anti-Cardiolipin, Multiple Autoantibodies Immunological Test SystemMID · Traditional | 11/27/2000SE |
| K991975 | Seraquest Eb Na IggLSE · Traditional | 11/02/1999SE |
| K990410 | Seraquest Eb Vca IggLSE · Traditional | 10/28/1999SE |
| K990977 | Seraquest Eb Vac IgmLJN · Traditional | 10/06/1999SE |
| K982485 | Seraquest CMV IgmLFZ · Traditional | 01/13/1999SE |
Questions and answers
When was Seraquest Anti-Ssa cleared by the FDA?
Seraquest Anti-Ssa (K980810) received a 510(k) decision of Substantially Equivalent on May 12, 1998, 70 days after the submission was received.
What is the product code of K980810?
The FDA product code is LJM – Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls, a Class II (moderate risk) device regulated under 21 CFR 866.5100.