K-number	K231974
Device name	PATHFAST®hs-cTnI-II
Applicant	Phc Corporation
Product code	MMI
Device class	Class II
Decision date	Mar 20, 2024
Decision	Substantially Equivalent
Regulation	862.1215

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Source

View the full FDA submission: accessdata.fda.gov

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PATHFAST®hs-cTnI-II

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