HALO AP Dx— 510(k) K252762

Substantially Equivalent

Indica Labs, LLC

FDA 510(k) clearance K252762 for HALO AP Dx, Substantially Equivalent on 2025-11-25. Applicant: Indica Labs, LLC. Device class: 2.

Clearance details

Applicant
Indica Labs, LLC
Product code
Code QKQ
Device class
Class 2
Regulation
21 CFR 864.3700
Advisory panel
Pathology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Albuquerque, NM, US
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