K-number	K212223
Device name	Atellica CH Enzymatic Creatinine_3 (ECre3)
Applicant	Siemens Healthcare Diagnostics, Inc.
Product code	JFY
Device class	Class II
Decision date	Nov 24, 2021
Decision	Substantially Equivalent
Regulation	862.1225

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Source

View the full FDA submission: accessdata.fda.gov

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Atellica CH Enzymatic Creatinine_3 (ECre3)

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