Epstein-Barr Viral Capsid Antigen Igm #5590
FDA 510(k) K883871 · Clinical Sciences, Inc.
510(k) numberK883871
Submission
- Device name
- Epstein-Barr Viral Capsid Antigen Igm #5590
- Applicant
- Clinical Sciences, Inc.
Whippany, NJ, US - Received
- September 13, 1988
- Decision date
- July 14, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K900688 | Varicella Zoster Igg Clin-Elisa Test KitLFY · Traditional | 05/15/1990SE |
| K883870 | Epstein-Barr Viral Capsid Antigen Igg #4590LSE · Traditional | 07/14/1989SE |
| K891990 | Rubeola Igg Clin-Elisa Test System, Cat. #4600LJB · Traditional | 06/15/1989SE |
| K883601 | Epstein-Barr Virus (EBNA-1) Igm Cata. #5550LLM · Traditional | 05/11/1989SE |
| K883600 | Epstein-Barr Virus (EBNA-1) Igg Cata. #4550LLM · Traditional | 05/11/1989SE |
| K874594 | Toxoplasma Igm Clin-Elisa(Tm) Cat # 5560LGD · Traditional | 03/07/1988SE |
| K872942 | Igm CMV Clin-Elisa(Tm) Test System Number: 5530LKQ · Traditional | 01/11/1988SE |
| K860145 | Rubella Elisa Test System Catalog Number: 4540LFX · Traditional | 07/14/1986SE |
| K860773 | Toxoplasma Igg Clin-Elisa Test Kit Cat. No. 4560LGD · Traditional | 05/23/1986SE |
| K854666 | Cytomegalovirus (CMV) Elisa Test Sys. Cat. NO:4530GQI · Traditional | 02/05/1986SE |
Questions and answers
When was Epstein-Barr Viral Capsid Antigen Igm #5590 cleared by the FDA?
Epstein-Barr Viral Capsid Antigen Igm #5590 (K883871) received a 510(k) decision of Substantially Equivalent on July 14, 1989, 304 days after the submission was received.
What is the product code of K883871?
The FDA product code is LSE – Epstein-Barr Virus, Other, a Class I (low risk) device regulated under 21 CFR 866.3235.