K-number	K231469
Device name	PAXgene® Blood DNA Tube
Applicant	Preanalytix GmbH
Product code	PJE
Device class	Class II
Decision date	Jun 21, 2023
Decision	Substantially Equivalent
Regulation	862.1675

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Source

View the full FDA submission: accessdata.fda.gov

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PAXgene® Blood DNA Tube

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