K-number	K233581
Device name	VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack
Applicant	Ortho Clinical Diagnostics
Product code	DHA
Device class	Class II
Decision date	May 8, 2024
Decision	Substantially Equivalent
Regulation	862.1155

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Source

View the full FDA submission: accessdata.fda.gov

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VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack

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