K-number	DEN230046
Device name	PGDx elio plasma focus Dx
Applicant	Personal Genome Diagnostics, Inc.
Product code	SBY
Device class	Class II
Decision date	Aug 1, 2024
Decision	Not Substantially Equivalent
Regulation	866.6085

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Source

View the full FDA submission: accessdata.fda.gov

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PGDx elio plasma focus Dx

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