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FDA 510(k)

RETINADX

K-Number: K003236 · 2000-11-02

ApplicantRegulatory Associates, Inc.
Decision Date2000-11-02
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

RETINADX is the device name listed in this FDA 510(k) record. The listed applicant is Regulatory Associates, Inc.. It received FDA 510(k) clearance on 2000-11-02 under 510(k) number K003236. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RETINADX?

RETINADX is a medical device that received FDA 510(k) clearance on 2000-11-02. The listed applicant is Regulatory Associates, Inc.. The 510(k) number is K003236.

When did RETINADX receive FDA 510(k) clearance?

RETINADX received FDA 510(k) clearance on 2000-11-02, under 510(k) number K003236.

Who is the listed applicant for RETINADX?

The FDA 510(k) record lists Regulatory Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RETINADX?

The FDA product code for RETINADX is HKI.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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