K-number	K191454
Device name	Atellica CH Amylase_2 (AMY_2)
Applicant	Siemens Healthcare Diagnostics, Inc.
Product code	JFJ
Device class	Class II
Decision date	Jul 30, 2019
Decision	Substantially Equivalent
Regulation	862.1070

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View the full FDA submission: accessdata.fda.gov

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Atellica CH Amylase_2 (AMY_2)

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