Name: Predicase
Price: 199 USD

K-number	K252329
Device name	QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B
Applicant	QIAGEN GmbH
Product code	PCH
Device class	Class II
Decision date	Oct 22, 2025
Decision	Substantially Equivalent
Regulation	866.3990

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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QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B

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