IMMULITE 2000 ANTI-CCP IGG ASSAY— 510(k) K121576
Substantially EquivalentSiemens Healthcare Diagnostics, Inc.
FDA 510(k) clearance K121576 for IMMULITE 2000 ANTI-CCP IGG ASSAY, Substantially Equivalent on 2013-04-04. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Product code
- Code NHX
- Device class
- Class 2
- Regulation
- 21 CFR 866.5775
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
Recent devices under product code NHX
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