K-number	K172201
Device name	Atellica IM Folate Assay
Applicant	Siemens Healthcare Diagnostics, Inc.
Product code	CGN
Device class	Class II
Decision date	Apr 12, 2018
Decision	Substantially Equivalent
Regulation	862.1295

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Source

View the full FDA submission: accessdata.fda.gov

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Atellica IM Folate Assay

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