Atellica CH Enzymatic Creatinine_3 (ECre3)— 510(k) K212223
Substantially EquivalentSiemens Healthcare Diagnostics, Inc.
FDA 510(k) clearance K212223 for Atellica CH Enzymatic Creatinine_3 (ECre3), Substantially Equivalent on 2021-11-24. Applicant: Siemens Healthcare Diagnostics, Inc..
Clearance details
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Product code
- Code JFY
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
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