K212223

Substantially Equivalent

Atellica CH Enzymatic Creatinine_3 (ECre3)

Applicant: Siemens Healthcare Diagnostics, Inc.
Product code: JFY
Advisory panel: Clinical Chemistry
Date received: 2021-07-16
Decision date: 2021-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

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