LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set
FDA 510(k) K162961 · DiaSorin, Inc.
510(k) numberK162961
Submission
- Device name
- LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set
- Applicant
- DiaSorin, Inc.
Stillwater, MN, US - Received
- October 24, 2016
- Decision date
- January 5, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| 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 |
| K021793 | Ebv Ea-D Igg Elisa Kit, Model EBG-100LSE · Traditional | Pan Bio Pty. , Ltd. | 09/27/2002SE |
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Questions and answers
When was LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set cleared by the FDA?
LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set (K162961) received a 510(k) decision of Substantially Equivalent on January 5, 2017, 73 days after the submission was received.
What is the product code of K162961?
The FDA product code is LSE – Epstein-Barr Virus, Other, a Class I (low risk) device regulated under 21 CFR 866.3235.