510(k) K171537
K171537 is an FDA 510(k) premarket notification submitted by Sebia for the device "CAPI 3 Hb A1c". The FDA issued a decision of Substantially Equivalent on September 12, 2017. The device falls under product code PDJ (Hemoglobin A1c Test System), a Class II device regulated under 21 CFR 862.1373. Sebia has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 12, 2017
- Date Received
- May 25, 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.