ADVIA Centaur HAV IgM Assay— 510(k) K161964
Substantially EquivalentSiemens Healthcare Diagnostics, Inc.
FDA 510(k) clearance K161964 for ADVIA Centaur HAV IgM Assay, Substantially Equivalent on 2016-10-13. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Product code
- Code LOL
- Device class
- Class 2
- Regulation
- 21 CFR 866.3310
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
Recent devices under product code LOL
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