IDx-DR— 510(k) DEN180001

Unknown

Idx, LLC

FDA 510(k) clearance DEN180001 for IDx-DR, Unknown on 2018-04-11. Applicant: Idx, LLC. Device class: 2.

Clearance details

Applicant
Idx, LLC
Product code
Code PIB
Device class
Class 2
Regulation
21 CFR 886.1100
Advisory panel
Ophthalmic
Date received
Decision date
Decision
Unknown
Clearance type
Direct
Location
Iowa City, IA, US
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