Ea-D Igm Elisa Test System
FDA 510(k) K982350 · Columbia Bioscience, Inc.
510(k) numberK982350
Submission
- Device name
- Ea-D Igm Elisa Test System
- Applicant
- Columbia Bioscience, Inc.
Columbia, MD, US - Received
- July 6, 1998
- Decision date
- November 25, 1998
- 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
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| 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 |
|---|---|---|
| K991274 | Mumps Igg Elisa Test SystemLJY · Traditional | 09/03/1999SE |
| K990462 | Is H. Pylori Igg Elisa Test SystemLYR · Traditional | 09/03/1999SE |
| K984228 | Is Anti-Tpo Igg Elisa Test SystemJZO · Traditional | 02/02/1999SE |
| K983606 | Is Borrelia Burgdorferi Igm Test SystemLSR · Traditional | 12/16/1998SE |
| K983605 | Is Borrelia Burgdorferi Igg/Igm Elisa Test SystemLSR · Traditional | 12/16/1998SE |
| K983553 | Anti-Tg Igg Elisa Test SystemJZO · Traditional | 12/07/1998SE |
| K982352 | Vca Igm Elisa Test SystemLSE · Traditional | 11/25/1998SE |
| K982348 | EBNA-1 Igm Elisa Test SystemLSE · Traditional | 11/25/1998SE |
| K983740 | IS-ANTI-PR3 Igg Elisa Test SystemMOB · Traditional | 11/18/1998SE |
| K983390 | Is-Anti-Mpo Igg Elisa Test SystemMOB · Traditional | 11/18/1998SE |
Questions and answers
When was Ea-D Igm Elisa Test System cleared by the FDA?
Ea-D Igm Elisa Test System (K982350) received a 510(k) decision of Substantially Equivalent on November 25, 1998, 142 days after the submission was received.
What is the product code of K982350?
The FDA product code is LSE – Epstein-Barr Virus, Other, a Class I (low risk) device regulated under 21 CFR 866.3235.