K-number	K221990
Device name	Access Total ßhCG (5th IS)
Applicant	Beckman Coulter, Inc.
Product code	DHA
Device class	Class II
Decision date	Dec 27, 2022
Decision	Substantially Equivalent
Regulation	862.1155

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Source

View the full FDA submission: accessdata.fda.gov

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Access Total ßhCG (5th IS)

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