K-number	K221197
Device name	VITROS Immunodiagnostic Products Intact PTH II Reagent Pack
Applicant	Ortho Clinical Diagnostics
Product code	CEW
Device class	Class II
Decision date	Sep 5, 2023
Decision	Substantially Equivalent
Regulation	862.1545

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Source

View the full FDA submission: accessdata.fda.gov

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VITROS Immunodiagnostic Products Intact PTH II Reagent Pack

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