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FDA 510(k)

CHROMOLITE EP

K-Number: K081619 · 2008-07-18

ApplicantChromogenex Technologies Limited
Decision Date2008-07-18
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CHROMOLITE EP is the device name listed in this FDA 510(k) record. The listed applicant is Chromogenex Technologies Limited. It received FDA 510(k) clearance on 2008-07-18 under 510(k) number K081619. 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 EP?

CHROMOLITE EP is a medical device that received FDA 510(k) clearance on 2008-07-18. The listed applicant is Chromogenex Technologies Limited. The 510(k) number is K081619.

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

CHROMOLITE EP received FDA 510(k) clearance on 2008-07-18, under 510(k) number K081619.

Who is the listed applicant for CHROMOLITE EP?

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

What is the FDA product code for CHROMOLITE EP?

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

Related Clinical Trials

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Other records listing Chromogenex Technologies Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K111501I-LIPO SYSTEM

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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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