K-number	DEN240032
Device name	APO-Easy Genotyping kit
Applicant	Firalis SA
Product code	SFC
Device class	Class II
Decision date	Jun 12, 2025
Decision	Not Substantially Equivalent
Regulation	866.5850

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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APO-Easy Genotyping kit

Everything you need for a 510(k) submission. Nothing you don't.