CardioPhase® hsCRP— 510(k) K232624
Substantially EquivalentSiemens Healthcare Diagnostic Products GmbH
FDA 510(k) clearance K232624 for CardioPhase® hsCRP, Substantially Equivalent on 2023-11-27. Applicant: Siemens Healthcare Diagnostic Products GmbH. Device class: 2.
Clearance details
- Applicant
- Siemens Healthcare Diagnostic Products GmbH
- Product code
- Code DCN
- Device class
- Class 2
- Regulation
- 21 CFR 866.5270
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marburg, DE
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More clearances from Siemens Healthcare Diagnostic Products GmbH
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