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FDA 510(k)

THE INTUITIVE COLORIMETER

K-Number: K012298 · 2001-09-26

ApplicantCerium Optical Technologies, Inc.
Decision Date2001-09-26
Product CodeNFD
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

THE INTUITIVE COLORIMETER is the device name listed in this FDA 510(k) record. The listed applicant is Cerium Optical Technologies, Inc.. It received FDA 510(k) clearance on 2001-09-26 under 510(k) number K012298. The device is classified under product code NFD. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE INTUITIVE COLORIMETER?

THE INTUITIVE COLORIMETER is a medical device that received FDA 510(k) clearance on 2001-09-26. The listed applicant is Cerium Optical Technologies, Inc.. The 510(k) number is K012298.

When did THE INTUITIVE COLORIMETER receive FDA 510(k) clearance?

THE INTUITIVE COLORIMETER received FDA 510(k) clearance on 2001-09-26, under 510(k) number K012298.

Who is the listed applicant for THE INTUITIVE COLORIMETER?

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

What is the FDA product code for THE INTUITIVE COLORIMETER?

The FDA product code for THE INTUITIVE COLORIMETER is NFD.

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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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