IDx-DR— 510(k) DEN180001
UnknownIdx, 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
Recent devices under product code PIB
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