RETINADX— 510(k) K003236
Substantially EquivalentRegulatory Associates, Inc.
FDA 510(k) clearance K003236 for RETINADX, Substantially Equivalent on 2000-11-02. Applicant: Regulatory Associates, Inc.. Device class: 2.
Clearance details
- Applicant
- Regulatory Associates, Inc.
- Product code
- Code HKI
- Device class
- Class 2
- Regulation
- 21 CFR 886.1120
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lakewood, CO, US
Recent devices under product code HKI
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