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 IDK003236
510k NumberK003236
Device Name:RETINADX
ClassificationCamera, Ophthalmic, Ac-powered
Applicant REGULATORY ASSOCIATES, INC. 777 SOUTH WADESWORTH BLVD., BLDG. 2, SUITE 102 Lakewood,  CO  80226
ContactKevin Walls
CorrespondentKevin Walls
REGULATORY ASSOCIATES, INC. 777 SOUTH WADESWORTH BLVD., BLDG. 2, SUITE 102 Lakewood,  CO  80226
Product CodeHKI  
CFR Regulation Number886.1120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-10-17
Decision Date2000-11-02

Trademark Results [RETINADX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
RETINADX
RETINADX
76027948 not registered Dead/Abandoned
Eye Expert, LLC
2000-04-18

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