The Aptus (Automated) Application of the Ebna Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for TH
FDA 510(k) K984133 · Zeus Scientific, Inc.
510(k) numberK984133
Submission
- Device name
- The Aptus (Automated) Application of the Ebna Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for TH
- Applicant
- Zeus Scientific, Inc.
Branchburg, NJ, US - Received
- November 18, 1998
- Decision date
- January 11, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K040120 | Diasorin Liaison Ebna Igg, Liaison Vca Igg, Liaison Vca Igm AssaysLLM · Traditional | DiaSorin, Inc. | 04/29/2005SE |
| 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 The Aptus (Automated) Application of the Ebna Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for TH cleared by the FDA?
The Aptus (Automated) Application of the Ebna Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for TH (K984133) received a 510(k) decision of Substantially Equivalent on January 11, 1999, 54 days after the submission was received.
What is the product code of K984133?
The FDA product code is LLM – Test, Antigen, Nuclear, Epstein-Barr Virus, a Class I (low risk) device regulated under 21 CFR 866.3235.