Epstein-Barr Virus Ebna-Igg Antibody Elisa Test
FDA 510(k) K911569 · Ortho Diagnostic Systems, Inc.
510(k) numberK911569
Submission
- Device name
- Epstein-Barr Virus Ebna-Igg Antibody Elisa Test
- Applicant
- Ortho Diagnostic Systems, Inc.
Carpinteria, CA, US - Received
- April 8, 1991
- Decision date
- June 10, 1991
- 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
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| K984133 | The Aptus (Automated) Application of the Ebna Igg Elisa Test System. an Enzyme Linked…LLM · Traditional | Zeus Scientific, Inc. | 01/11/1999SE |
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| K980598 | EBNA-1 Igm Elisa Test SystemLLM · Traditional | Clark Laboratories, Inc. | 05/01/1998SE |
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| 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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| K950482 | Ortho-Mune Ok-Comvo CD3-FITC/CD8-PE (Okt 3/OKT8) Monoclonal Antibody (Murine)GKZ · Traditional | 05/10/1996SE |
| K935720 | Ortho Count Calibration Kit for Ortho Cytoronabsolute Laser Flow Cytometry SystemGKZ · Traditional | 05/09/1996SE |
| K954570 | Ortho Immunocount Flow Cytometry SystemGKZ · Traditional | 04/30/1996SE |
Questions and answers
When was Epstein-Barr Virus Ebna-Igg Antibody Elisa Test cleared by the FDA?
Epstein-Barr Virus Ebna-Igg Antibody Elisa Test (K911569) received a 510(k) decision of Substantially Equivalent on June 10, 1991, 63 days after the submission was received.
What is the product code of K911569?
The FDA product code is LLM – Test, Antigen, Nuclear, Epstein-Barr Virus, a Class I (low risk) device regulated under 21 CFR 866.3235.