510(k) K173206
K173206 is an FDA 510(k) premarket notification submitted by Sekisui Diagnostics P.E.I., Inc. for the device "SEKURE HbA1c Assay". The FDA issued a decision of Substantially Equivalent on July 12, 2018. The device falls under product code PDJ (Hemoglobin A1c Test System), a Class II device regulated under 21 CFR 862.1373. Sekisui Diagnostics P.E.I., Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 12, 2018
- Date Received
- October 2, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hemoglobin A1c Test System
- Device Class
- Class II
- Regulation Number
- 862.1373
- Review Panel
- CH
- Submission Type
Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes.