Ebv-Vca Igg Elisa Test System
FDA 510(k) K981812 · Diamedix Corp.
510(k) numberK981812
Submission
- Device name
- Ebv-Vca Igg Elisa Test System
- Applicant
- Diamedix Corp.
Columbia, MD, US - Received
- May 22, 1998
- Decision date
- March 4, 1999
- 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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| 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 |
|---|---|---|
| K093101 | Mago 4SLFX · Traditional | 01/21/2011SE |
| K021394 | Diamedix Is-Rheumatoid Factor Test SystemDHR · Traditional | 07/09/2002SE |
| K013956 | Diamedix IS-ANTI-B2 Glycoprotein I ScreenMSV · Traditional | 01/08/2002SE |
| K013628 | Diamedix IS-ANTI-B2 Glycoprotein I Igg/Igm Test SystemMSV · Traditional | 12/21/2001SE |
| K012450 | Diamedix Is-Anti-Cardiolipin Iga Test SystemMID · Traditional | 10/26/2001SE |
| K012449 | Diamedix Is-Anti-Cardiolipin Igg/Igm Test SystemMID · Traditional | 10/26/2001SE |
| K012797 | Diamedix Is-Anti-Gliadin Iga Test SystemMST · Traditional | 09/28/2001SE |
| K012795 | Diamedix Is-Anti-Gliadin Igg Test SystemMST · Traditional | 09/28/2001SE |
| K012053 | Diamedix Is-Anti-Cardiolipin Screen Test SystemMID · Traditional | 08/20/2001SE |
| K002262 | Diamedix Is-Hsv 1&2 Igm Test SystemLGC · Traditional | 11/28/2000SE |
Questions and answers
When was Ebv-Vca Igg Elisa Test System cleared by the FDA?
Ebv-Vca Igg Elisa Test System (K981812) received a 510(k) decision of Substantially Equivalent on March 4, 1999, 286 days after the submission was received.
What is the product code of K981812?
The FDA product code is LSE – Epstein-Barr Virus, Other, a Class I (low risk) device regulated under 21 CFR 866.3235.