K-number	K231927
Device name	Elecsys PTH , Elecsys PTH STAT
Applicant	Roche Diagnostics
Product code	CEW
Device class	Class II
Decision date	Mar 22, 2024
Decision	Substantially Equivalent
Regulation	862.1545

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View the full FDA submission: accessdata.fda.gov

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Elecsys PTH , Elecsys PTH STAT

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