Seraquest Eb Vca Igg
FDA 510(k) K990410 · Quest Intl., Inc.
510(k) numberK990410
Submission
- Device name
- Seraquest Eb Vca Igg
- Applicant
- Quest Intl., Inc.
North Miami, FL, US - Received
- February 9, 1999
- Decision date
- October 28, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LSE – Epstein-Barr Virus, Other
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3235
- Specialty
- Microbiology
Other 510(k)s with product code LSE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K233606 | ADVIA Centaur EBV-VCA IgMLSE · Traditional | Biokit, S.A. | 08/07/2024SE |
| K162961 | LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON®…LSE · Special | DiaSorin, Inc. | 01/05/2017SE |
| K162959 | LIAISON® EA IgG and LIAISON® EA IgG Serum Control SetLSE · Special | DiaSorin, Inc. | 01/04/2017SE |
| K091260 | Seraquest Ebv Ea-D Igg TestLSE · Traditional | Quest Intl., Inc. | 06/08/2009SE |
| K073382 | Plexus Ebv Igg Multi-Analyte Diagnostics, Model: MP0500GLSE · Traditional | Focus Diagnostics, Inc. | 07/28/2008SE |
| K062213 | Bioplex 2200 Ebv Igm Panel on Bioplex 2200 Multi-Analyte Detection SystemLSE · Traditional | Bio-Rad Laboratories, Inc. | 12/08/2006SE |
| K062211 | Bioplex 2200 Ebv Igg Panel for Bioplex 2200 Multi-Analyte Detection SystemLSE · Traditional | Bio-Rad Laboratories, Inc. | 12/08/2006SE |
| K060204 | Liaison Ea IggLSE · Traditional | DiaSorin, Inc. | 10/18/2006SE |
| K033915 | Modification to Seraquest Eb Vca IggLSE · Special | Quest Intl., Inc. | 01/16/2004SE |
| K030863 | Ebv VCA-P18 Igg ElisaLSE · Traditional | Panbio Limited | 06/27/2003SE |
More from Panbio Limited
| 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 |
| K990977 | Seraquest Eb Vac IgmLJN · Traditional | 10/06/1999SE |
| K982485 | Seraquest CMV IgmLFZ · Traditional | 01/13/1999SE |
| K982281 | Seraquest Rubella IgmLFX · Traditional | 10/16/1998SE |
Questions and answers
When was Seraquest Eb Vca Igg cleared by the FDA?
Seraquest Eb Vca Igg (K990410) received a 510(k) decision of Substantially Equivalent on October 28, 1999, 261 days after the submission was received.
What is the product code of K990410?
The FDA product code is LSE – Epstein-Barr Virus, Other, a Class I (low risk) device regulated under 21 CFR 866.3235.