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FDA 510(k)

CHROMOLITE SYSTEM

K-Number: K053324 · 2006-01-05

ApplicantChromogenex Plc
Decision Date2006-01-05
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CHROMOLITE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Chromogenex Plc. It received FDA 510(k) clearance on 2006-01-05 under 510(k) number K053324. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHROMOLITE SYSTEM?

CHROMOLITE SYSTEM is a medical device that received FDA 510(k) clearance on 2006-01-05. The listed applicant is Chromogenex Plc. The 510(k) number is K053324.

When did CHROMOLITE SYSTEM receive FDA 510(k) clearance?

CHROMOLITE SYSTEM received FDA 510(k) clearance on 2006-01-05, under 510(k) number K053324.

Who is the listed applicant for CHROMOLITE SYSTEM?

The FDA 510(k) record lists Chromogenex Plc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHROMOLITE SYSTEM?

The FDA product code for CHROMOLITE SYSTEM is GEX. This falls under the Gastroenterology category.

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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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