ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay— 510(k) K171771
Substantially EquivalentSiemens Healthcare Diagnostics, Inc.
FDA 510(k) clearance K171771 for ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay, Substantially Equivalent on 2017-12-04. 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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