Incstar Epstein-Barr Nuclear Antigen (Ebna_ Igg Elisa Kit
FDA 510(k) K946158 · Incstar Corp.
510(k) numberK946158
Submission
- Device name
- Incstar Epstein-Barr Nuclear Antigen (Ebna_ Igg Elisa Kit
- Applicant
- Incstar Corp.
Stillwater, MN, US - Received
- December 8, 1994
- Decision date
- June 9, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| K932742 | Ebna Igg Elisa Test SystemLLM · Traditional | Zeus Scientific, Inc. | 05/05/1995SE |
More from Zeus Scientific, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K963289 | Incstar Toxoplasma Igm Capture Elisa AssayLGD · Traditional | 05/01/1997SE |
| K963297 | Incstar Toxoplasma Igg Fast Elisa Assay (CAT.#7560)LGD · Traditional | 12/16/1996SE |
| K963296 | Incstar Toxoplasma Igg Alisa Assay (CAT.#7565)LGD · Traditional | 12/16/1996SE |
| K960367 | Incstar Rubella Igg Elisa AssayLFX · Traditional | 10/24/1996SE |
| K960358 | Incstar Rubella Igg Fast Elisa AssayLFX · Traditional | 10/24/1996SE |
| K960434 | Incstar Cytomegalovirus Igm Capture Elisa Assay Model 8530LFZ · Traditional | 10/17/1996SE |
| K953567 | Incstar 25-HYDROXYVITMIN D 1251 RiaMRG · Traditional | 09/25/1996SE |
| K955363 | Incstar HSZ I/Ii Igg Elisa AssayIGC · Traditional | 07/24/1996SE |
| K955362 | Incstar HSV I/Ii Igg Fast Elisa AssayIGC · Traditional | 07/24/1996SE |
| K955361 | Incstar Cytomegalovirus Igg Elisa AssayLFZ · Traditional | 07/22/1996SE |
Questions and answers
When was Incstar Epstein-Barr Nuclear Antigen (Ebna_ Igg Elisa Kit cleared by the FDA?
Incstar Epstein-Barr Nuclear Antigen (Ebna_ Igg Elisa Kit (K946158) received a 510(k) decision of Substantially Equivalent on June 9, 1995, 183 days after the submission was received.
What is the product code of K946158?
The FDA product code is LLM – Test, Antigen, Nuclear, Epstein-Barr Virus, a Class I (low risk) device regulated under 21 CFR 866.3235.