LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set
FDA 510(k) K162969 · DiaSorin, Inc.
510(k) numberK162969
Submission
- Device name
- LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set
- Applicant
- DiaSorin, Inc.
Stillwater, MN, US - Received
- October 24, 2016
- Decision date
- January 6, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LFZ – Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3175
- Specialty
- Microbiology
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|---|---|---|---|
| K220949 | Architect CMV IgGLFZ · Traditional | Abbott Laboratories | 10/27/2022SE |
| K220911 | Elecsys CMV IgGLFZ · Traditional | Roche Diagnostics | 10/12/2022SE |
| K181213 | ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality ControlLFZ · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/30/2018SE |
| K163569 | Elecsys CMV IgMLFZ · Traditional | Roche Diagnostics | 03/17/2017SE |
| K142133 | Elecys CMV Igm Immunoassay; Elecys Precicontrol CMV IgmLFZ · Traditional | Roche Diagnostics | 10/24/2014SE |
| K131605 | Elecsys Precicontrol CMV Igg, Elecsys CMV Igg ImmunoassayLFZ · Traditional | Roche Diagnostics | 02/28/2014SE |
| K040290 | Diasorin Liaison CMV Igm/IggLFZ · Traditional | Diasorin S.P.A | 06/01/2005SE |
| K993952 | Immulite 2000 CMV Igg, Model L2KCV2, L2KCV6LFZ · Special | Diagnostic Products Corp. | 12/16/1999SE |
| K982485 | Seraquest CMV IgmLFZ · Traditional | Quest Intl., Inc. | 01/13/1999SE |
| K984139 | The Aptus (Automated) Application of the CMV Igg Elisa Test System. an Enzyme Linked…LFZ · Traditional | Zeus Scientific, Inc. | 01/11/1999SE |
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Questions and answers
When was LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set cleared by the FDA?
LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set (K162969) received a 510(k) decision of Substantially Equivalent on January 6, 2017, 74 days after the submission was received.
What is the product code of K162969?
The FDA product code is LFZ – Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus, a Class II (moderate risk) device regulated under 21 CFR 866.3175.