510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K031604Substantially Equivalent

Glycomark

Tomen America, Inc., New York NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K031604 is the FDA 510(k) clearance record for GLYCOMARK, a class II device, cleared for Tomen America, Inc. on under FDA product code NOZ (Assay, 1,5-Anhydroglucitol (15ag)). FDA's definition for product code NOZ reads: "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". FDA records list one 510(k) clearance for Tomen America, Inc. As of , FDA records show no recalls naming K031604.

Clearance record

Decision date
Received
(123 days to decision)
Product code
NOZ Assay, 1,5-Anhydroglucitol (15ag)
Regulation
21 CFR 864.7470
Device class
Class II
Review panel
Hematology
Applicant
Tomen America, Inc. 1285 Ave. Of The Americas, New York NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NOZ

Trailing 12 months

FDA records hold no clearances under product code NOZ in the trailing twelve months.

FDA records show no clearances under product code NOZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NOZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260