LIAISON VZV IgG HT, LIAISON Control VZV IgG HT
FDA 510(k) K231214 · DiaSorin, Inc.
510(k) numberK231214
Submission
- Device name
- LIAISON VZV IgG HT, LIAISON Control VZV IgG HT
- Applicant
- DiaSorin, Inc.
Stillwater, MN, US - Received
- April 28, 2023
- Decision date
- October 27, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LFY – Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3900
- Specialty
- Microbiology
Other 510(k)s with product code LFY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K150375 | LIAISON VZV IgG, LIAISON Control VZV IgGLFY · Special | DiaSorin, Inc. | 03/11/2015SE |
| K070317 | Zeus Scientific, Inc VZV Igm Elisa Test SystemLFY · Traditional | Zeus Scientific, Inc. | 07/05/2007SE |
| K061820 | Diasorin Liaison VZV IggLFY · Traditional | DiaSorin, Inc. | 02/26/2007SE |
| K051484 | Zeus Scientific, Inc., Athena Multi-Lyte MMRV Igg Test System.LFY · Traditional | Zeus Scientific, Inc. | 12/05/2005SE |
| K984181 | The Aptus (Automated) Application of the VZV Igg Elisa Test SystemLFY · Traditional | Zeus Scientific, Inc. | 01/22/1999SE |
| K981867 | Is-Vzu Igg Test SystemLFY · Traditional | Diamedix Corp. | 09/28/1998SE |
| K972295 | Seraquest VZV IggLFY · Traditional | Quest Intl., Inc. | 11/05/1997SE |
| K961012 | VZV Igg Elisa Test SystemLFY · Traditional | Zeus Scientific, Inc. | 07/24/1996SE |
| K943843 | Varicelisa, ModificationLFY · Traditional | Biowhittaker Molecular Applications, Inc. | 03/14/1996SE |
| K941046 | VZV Igg Elisa TestLFY · Traditional | Gull Laboratories, Inc. | 08/24/1995SE |
More from Gull Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260770 | LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteXLOM · Traditional | 06/04/2026SE |
| K223403 | LIAISON Anti-HAV; LIAISON XSLOL · Special | 12/09/2022SE |
| K213858 | LIAISON Calprotectin, LIAISON Q.S.E.T. Device PlusNXO · Traditional | 07/26/2022SE |
| K213936 | LIAISON MeMed BV, LIAISON MeMed BV Control SetQPS · Traditional | 07/14/2022SE |
| K193650 | LIAISON FerritinDBF · Traditional | 09/14/2021SE |
| K202574 | LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody PlusLSR · Traditional | 02/18/2021SE |
| K202573 | LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody PlusLSR · Traditional | 02/18/2021SE |
| K210272 | LIAISON Anti-HAVLOL · Special | 02/09/2021SE |
| K201908 | LIAISON Testosterone xtCDZ · Special | 10/15/2020SE |
| K192586 | LIAISON® FolateCGN · Traditional | 05/06/2020SE |
Questions and answers
When was LIAISON VZV IgG HT, LIAISON Control VZV IgG HT cleared by the FDA?
LIAISON VZV IgG HT, LIAISON Control VZV IgG HT (K231214) received a 510(k) decision of Substantially Equivalent on October 27, 2023, 182 days after the submission was received.
What is the product code of K231214?
The FDA product code is LFY – Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster, a Class II (moderate risk) device regulated under 21 CFR 866.3900.