510(k) K192369
K192369 is an FDA 510(k) premarket notification submitted by Ixensor Co, Ltd. for the device "PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit". The FDA issued a decision of Substantially Equivalent on October 29, 2019. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470. Ixensor Co, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 29, 2019
- Date Received
- August 30, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Assay, Glycosylated Hemoglobin
- Device Class
- Class II
- Regulation Number
- 864.7470
- Review Panel
- HE
- Submission Type