K-number	K111452
Device name	PRESAGE ST2 ASSAY
Applicant	Critical Care Diagnostics, Inc. (Dba Critical Diag
Product code	OYG
Device class	Class II
Decision date	Dec 9, 2011
Decision	Substantially Equivalent
Regulation	862.1117

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Source

View the full FDA submission: accessdata.fda.gov

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PRESAGE ST2 ASSAY

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