Unknown
FDA 510(k) K934774 · Granbio, Inc.
510(k) numberK934774
Submission
- Device name
- Unknown
- Applicant
- Granbio, Inc.
Temecula, CA, US - Received
- October 5, 1993
- Decision date
- April 20, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LSE – Epstein-Barr Virus, Other
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3235
- Specialty
- Microbiology
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|---|---|---|---|
| K233606 | ADVIA Centaur EBV-VCA IgMLSE · Traditional | Biokit, S.A. | 08/07/2024SE |
| K162961 | LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON®…LSE · Special | DiaSorin, Inc. | 01/05/2017SE |
| K162959 | LIAISON® EA IgG and LIAISON® EA IgG Serum Control SetLSE · Special | DiaSorin, Inc. | 01/04/2017SE |
| K091260 | Seraquest Ebv Ea-D Igg TestLSE · Traditional | Quest Intl., Inc. | 06/08/2009SE |
| K073382 | Plexus Ebv Igg Multi-Analyte Diagnostics, Model: MP0500GLSE · Traditional | Focus Diagnostics, Inc. | 07/28/2008SE |
| K062213 | Bioplex 2200 Ebv Igm Panel on Bioplex 2200 Multi-Analyte Detection SystemLSE · Traditional | Bio-Rad Laboratories, Inc. | 12/08/2006SE |
| K062211 | Bioplex 2200 Ebv Igg Panel for Bioplex 2200 Multi-Analyte Detection SystemLSE · Traditional | Bio-Rad Laboratories, Inc. | 12/08/2006SE |
| K060204 | Liaison Ea IggLSE · Traditional | DiaSorin, Inc. | 10/18/2006SE |
| K033915 | Modification to Seraquest Eb Vca IggLSE · Special | Quest Intl., Inc. | 01/16/2004SE |
| K030863 | Ebv VCA-P18 Igg ElisaLSE · Traditional | Panbio Limited | 06/27/2003SE |
More from Panbio Limited
| 510(k) | Device | Decision |
|---|---|---|
| K951822 | Ebna Enzyme Immunoassay KitLLM · Traditional | 02/15/1996SE |
| K901840 | (Eia) for Igm Antibody to Ebv Vca in Human SerumLJN · Traditional | 09/12/1990SE |
| K901156 | Eia for Igg Antibody to Ebv Vca in Human SerumGNP · Traditional | 09/12/1990SE |
| K881617 | Indirect Immunofluorescent Antibody AssayLSE · Traditional | 06/07/1988SE |
| K871298 | Ebna Acif Assay KitLLM · Traditional | 06/25/1987SE |
| K864604 | Ebv Vca Igm Antibody Assay KitLJN · Traditional | 02/02/1987SE |
| K864347 | Indirect Immunofluorescent Antibody Assay/ Ebv-VcaGNP · Traditional | 02/02/1987SE |
Questions and answers
When was Unknown cleared by the FDA?
Unknown (K934774) received a 510(k) decision of Substantially Equivalent on April 20, 1994, 197 days after the submission was received.
What is the product code of K934774?
The FDA product code is LSE – Epstein-Barr Virus, Other, a Class I (low risk) device regulated under 21 CFR 866.3235.