RETINADX
Camera, Ophthalmic, Ac-powered
REGULATORY ASSOCIATES, INC.
The following data is part of a premarket notification filed by Regulatory Associates, Inc. with the FDA for Retinadx.
Pre-market Notification Details
| Device ID | K003236 |
| 510k Number | K003236 |
| Device Name: | RETINADX |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | REGULATORY ASSOCIATES, INC. 777 SOUTH WADESWORTH BLVD., BLDG. 2, SUITE 102 Lakewood, CO 80226 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls REGULATORY ASSOCIATES, INC. 777 SOUTH WADESWORTH BLVD., BLDG. 2, SUITE 102 Lakewood, CO 80226 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-17 |
| Decision Date | 2000-11-02 |
Trademark Results [RETINADX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RETINADX 76027948 not registered Dead/Abandoned |
Eye Expert, LLC 2000-04-18 |
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