K-number	K252762
Device name	HALO AP Dx
Applicant	Indica Labs, LLC
Product code	QKQ
Device class	Class II
Decision date	Nov 25, 2025
Decision	Substantially Equivalent
Regulation	864.3700

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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HALO AP Dx

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