K-number	K250588
Device name	Access Rubella IgG
Applicant	Beckman Coulter, Inc.
Product code	LFX
Device class	Class II
Decision date	Nov 17, 2025
Decision	Substantially Equivalent
Regulation	866.3510

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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Access Rubella IgG

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