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FDA 510(k)

HALO AP Dx

K-Number: K252762 · 2025-11-25

ApplicantIndica Labs, LLC
Decision Date2025-11-25
Product CodeQKQ
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

HALO AP Dx is a medical device manufactured by Indica Labs, LLC. It received FDA 510(k) clearance on 2025-11-25 under approval number K252762. The device is classified under product code QKQ. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HALO AP Dx?

HALO AP Dx is a medical device that received FDA 510(k) clearance on 2025-11-25. It is manufactured by Indica Labs, LLC. The 510(k) number is K252762.

When was HALO AP Dx approved by the FDA?

HALO AP Dx received FDA 510(k) clearance on 2025-11-25, under approval number K252762.

What company makes HALO AP Dx?

HALO AP Dx is manufactured by Indica Labs, LLC.

What is the FDA product code for HALO AP Dx?

The FDA product code for HALO AP Dx is QKQ.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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