FDA 510(k)

GLYCOMARK

K-Number: K031604 · 2003-09-22

Decision Date2003-09-22

Product CodeNOZ

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

GLYCOMARK is the device name listed in this FDA 510(k) record. The listed applicant is Tomen America, Inc.. It received FDA 510(k) clearance on 2003-09-22 under 510(k) number K031604. The device is classified under product code NOZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLYCOMARK?

GLYCOMARK is a medical device that received FDA 510(k) clearance on 2003-09-22. The listed applicant is Tomen America, Inc.. The 510(k) number is K031604.

When did GLYCOMARK receive FDA 510(k) clearance?

GLYCOMARK received FDA 510(k) clearance on 2003-09-22, under 510(k) number K031604.

Who is the listed applicant for GLYCOMARK?

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

What is the FDA product code for GLYCOMARK?

The FDA product code for GLYCOMARK is NOZ.

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Related Devices (Code: NOZ)

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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.