NOZ
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Assay, 1,5-Anhydroglucitol (15ag)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7470
- Medical specialty
- Hematology
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Diazyme 1,5-AG Assay (K180209) | Diazyme Laboratories, Inc. | 2018-10-04 |
| GLYCOMARK (K031604) | Tomen America, Inc. | 2003-09-22 |
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Every clearance here is in the API, with alerts when new ones post.