510(k) K031604
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 22, 2003
- Date Received
- May 22, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Assay, 1,5-Anhydroglucitol (15ag)
- Device Class
- Class II
- Regulation Number
- 864.7470
- Review Panel
- HE
- Submission Type
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.