EBNA-1 Igm Elisa Test System
FDA 510(k) K980598 · Clark Laboratories, Inc.
510(k) numberK980598
Submission
- Device name
- EBNA-1 Igm Elisa Test System
- Applicant
- Clark Laboratories, Inc.
Frederick, MD, US - Received
- February 17, 1998
- Decision date
- May 1, 1998
- 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 |
| 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 |
| 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 |
More from Zeus Scientific, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K980912 | Vca Igg Elisa Test SystemLSE · Traditional | 07/22/1998SE |
| K980596 | Vca Igm Elisa Test SystemLSE · Traditional | 07/22/1998SE |
| K973123 | Ea-D Igg Elisa Test SystemLSE · Traditional | 03/26/1998SE |
| K931543 | Encore Ena Combined EiaLLL · Traditional | 09/08/1993SE |
| K925826 | Encore Thyroglobulin Ige, Iga and Igm EiaJZO · Traditional | 01/26/1993SE |
| K923537 | Encore Ds-DnaLRM · Traditional | 12/23/1992SE |
| K921870 | Encore Sm/RnpLLL · Traditional | 12/01/1992SE |
| K921572 | Encore SMLLL · Traditional | 12/01/1992SE |
| K922340 | Encore Ss-BLLL · Traditional | 10/16/1992SE |
| K922157 | Encore Ss-ALLL · Traditional | 10/13/1992SE |
Questions and answers
When was EBNA-1 Igm Elisa Test System cleared by the FDA?
EBNA-1 Igm Elisa Test System (K980598) received a 510(k) decision of Substantially Equivalent on May 1, 1998, 73 days after the submission was received.
What is the product code of K980598?
The FDA product code is LLM – Test, Antigen, Nuclear, Epstein-Barr Virus, a Class I (low risk) device regulated under 21 CFR 866.3235.