N Latex Cystatin C; N Protein Standard UY— 510(k) K171072
Substantially EquivalentSiemens Healthcare Diagnostics Products GmbH
FDA 510(k) clearance K171072 for N Latex Cystatin C; N Protein Standard UY, Substantially Equivalent on 2017-05-12. Applicant: Siemens Healthcare Diagnostics Products GmbH. Device class: 2.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics Products GmbH
- Product code
- Code NDY
- Device class
- Class 2
- Regulation
- 21 CFR 862.1225
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marburg, DE
Recent devices under product code NDY
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