ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control— 510(k) K181213
Substantially EquivalentSiemens Healthcare Diagnostics, Inc.
FDA 510(k) clearance K181213 for ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control, Substantially Equivalent on 2018-07-30. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Product code
- Code LFZ
- Device class
- Class 2
- Regulation
- 21 CFR 866.3175
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
Recent devices under product code LFZ
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