ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control
FDA 510(k) K181213 · Siemens Healthcare Diagnostics, Inc.
510(k) numberK181213
Submission
- Device name
- ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control
- Applicant
- Siemens Healthcare Diagnostics, Inc.
Tarrytown, NY, US - Received
- May 7, 2018
- Decision date
- July 30, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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| K162969 | LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control SetLFZ · Special | DiaSorin, Inc. | 01/06/2017SE |
| 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 ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control cleared by the FDA?
ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control (K181213) received a 510(k) decision of Substantially Equivalent on July 30, 2018, 84 days after the submission was received.
What is the product code of K181213?
The FDA product code is LFZ – Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus, a Class II (moderate risk) device regulated under 21 CFR 866.3175.