Ebna Igg Elisa Test System
FDA 510(k) K932742 · Zeus Scientific, Inc.
510(k) numberK932742
Submission
- Device name
- Ebna Igg Elisa Test System
- Applicant
- Zeus Scientific, Inc.
Raritan, NJ, US - Received
- June 8, 1993
- Decision date
- May 5, 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
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| 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 |
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Questions and answers
When was Ebna Igg Elisa Test System cleared by the FDA?
Ebna Igg Elisa Test System (K932742) received a 510(k) decision of Substantially Equivalent on May 5, 1995, 696 days after the submission was received.
What is the product code of K932742?
The FDA product code is LLM – Test, Antigen, Nuclear, Epstein-Barr Virus, a Class I (low risk) device regulated under 21 CFR 866.3235.