Cleared Traditional

GLYCOMARK

K031604 · Tomen America, Inc. · Chemistry
Sep 2003
Decision
123d
Days
Class 2
Risk

About This 510(k) Submission

K031604 is an FDA 510(k) clearance for the GLYCOMARK, a Assay, 1,5-anhydroglucitol (15ag) (Class II — Special Controls, product code NOZ), submitted by Tomen America, Inc. (New York, US). The FDA issued a Cleared decision on September 22, 2003, 123 days after receiving the submission on May 22, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7470.

Submission Details

510(k) Number K031604 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 2003
Decision Date September 22, 2003
Days to Decision 123 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code NOZ — Assay, 1,5-anhydroglucitol (15ag)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7470
Definition The Test Provides Quantitative Measurement Of 1,5-anhydroglucitol (15ag) In Patient's Blood. The Test Is For Professional Use, And Is Indicated For The Monitoring Of Glycemic Control In People With Diabetes.