Clearance Summary
PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT received FDA 510(k) clearance under submission number K103788, sponsored by HORIBA ABX SAS. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2011-11-08.
- Submission: K103788
- Applicant / Sponsor: HORIBA ABX SAS
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1345
- Decision date: 2011-11-08
Classification & Regulation
This clearance is catalogued under FDA product code CFR and 21 CFR 862.1345, within the Clinical Chemistry review panel as a Class II device.