Epstein-Barr Virus (EBNA-1) Igm Cata. #5550
FDA 510(k) K883601 · Clinical Sciences, Inc.
510(k) numberK883601
Submission
- Device name
- Epstein-Barr Virus (EBNA-1) Igm Cata. #5550
- Applicant
- Clinical Sciences, Inc.
Whippany, NJ, US - Received
- August 23, 1988
- Decision date
- May 11, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LLM – Test, Antigen, Nuclear, Epstein-Barr Virus
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3235
- Specialty
- Microbiology
Other 510(k)s with product code LLM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K233605 | ADVIA Centaur EBV-EBNA IgGLLM · Traditional | Biokit, S.A. | 08/07/2024SE |
| K040120 | Diasorin Liaison Ebna Igg, Liaison Vca Igg, Liaison Vca Igm AssaysLLM · Traditional | DiaSorin, Inc. | 04/29/2005SE |
| K984133 | The Aptus (Automated) Application of the Ebna Igg Elisa Test System. an Enzyme Linked…LLM · Traditional | Zeus Scientific, Inc. | 01/11/1999SE |
| K973941 | Immunowell Ebna Igg TestLLM · Traditional | Genbio | 08/10/1998SE |
| K980598 | EBNA-1 Igm Elisa Test SystemLLM · Traditional | Clark Laboratories, Inc. | 05/01/1998SE |
| K951549 | Ebna Igg Eia Test SystemLLM · Traditional | Immunoprobe, Inc. | 04/29/1996SE |
| K951822 | Ebna Enzyme Immunoassay KitLLM · Traditional | Granbio, Inc. | 02/15/1996SE |
| K935730 | Ebna Igg Elisa TestLLM · Traditional | Gull Laboratories, Inc. | 09/19/1995SE |
| K946353 | Epstein-Barr Virus Nuclear Antigen Recombinant Immunofluorescent AssayLLM · Traditional | Mrl Diagnostics | 07/21/1995SE |
| K946158 | Incstar Epstein-Barr Nuclear Antigen (Ebna_ Igg Elisa KitLLM · Traditional | Incstar Corp. | 06/09/1995SE |
More from Incstar Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K900688 | Varicella Zoster Igg Clin-Elisa Test KitLFY · Traditional | 05/15/1990SE |
| K883871 | Epstein-Barr Viral Capsid Antigen Igm #5590LSE · Traditional | 07/14/1989SE |
| 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 |
| 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 Virus (EBNA-1) Igm Cata. #5550 cleared by the FDA?
Epstein-Barr Virus (EBNA-1) Igm Cata. #5550 (K883601) received a 510(k) decision of Substantially Equivalent on May 11, 1989, 261 days after the submission was received.
What is the product code of K883601?
The FDA product code is LLM – Test, Antigen, Nuclear, Epstein-Barr Virus, a Class I (low risk) device regulated under 21 CFR 866.3235.