NOZ · Class II · 21 CFR 864.7470

FDA Product Code NOZ: Assay, 1,5-anhydroglucitol (15ag)

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.

Leading manufacturers include Diazyme Laboratories, Inc..

2
Total
2
Cleared
188d
Avg days
2003
Since

FDA 510(k) Cleared Assay, 1,5-anhydroglucitol (15ag) Devices (Product Code NOZ)

2 devices
1–2 of 2
Cleared Oct 04, 2018
Diazyme 1,5-AG Assay
K180209
Diazyme Laboratories, Inc.
Chemistry · 253d

About Product Code NOZ - Regulatory Context