Diasorin Liaison Ebna Igg, Liaison Vca Igg, Liaison Vca Igm Assays
FDA 510(k) K040120 · DiaSorin, Inc.
510(k) numberK040120
Submission
- Device name
- Diasorin Liaison Ebna Igg, Liaison Vca Igg, Liaison Vca Igm Assays
- Applicant
- DiaSorin, Inc.
Stillwater, MN, US - Received
- January 20, 2004
- Decision date
- April 29, 2005
- 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
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|---|---|---|---|
| K233605 | ADVIA Centaur EBV-EBNA IgGLLM · Traditional | Biokit, S.A. | 08/07/2024SE |
| 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 |
| K932742 | Ebna Igg Elisa Test SystemLLM · Traditional | Zeus Scientific, Inc. | 05/05/1995SE |
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Questions and answers
When was Diasorin Liaison Ebna Igg, Liaison Vca Igg, Liaison Vca Igm Assays cleared by the FDA?
Diasorin Liaison Ebna Igg, Liaison Vca Igg, Liaison Vca Igm Assays (K040120) received a 510(k) decision of Substantially Equivalent on April 29, 2005, 465 days after the submission was received.
What is the product code of K040120?
The FDA product code is LLM – Test, Antigen, Nuclear, Epstein-Barr Virus, a Class I (low risk) device regulated under 21 CFR 866.3235.