Dimension Hemoglobin A1c Assay— 510(k) K173909
Substantially EquivalentSiemens Healthcare Diagnostics, Inc.
FDA 510(k) clearance K173909 for Dimension Hemoglobin A1c Assay, Substantially Equivalent on 2018-07-13. Applicant: Siemens Healthcare Diagnostics, Inc..
Clearance details
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Product code
- Code PDJ
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newark, DE, US
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