Clearance Summary
ABX PENTRA MICRO ALB CONTROL L/H received FDA 510(k) clearance under submission number K133676, sponsored by HORIBA ABX SAS. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2014-07-11.
- Submission: K133676
- Applicant / Sponsor: HORIBA ABX SAS
- Clearance pathway: Abbreviated
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 2014-07-11
Classification & Regulation
This clearance is catalogued under FDA product code JJY and 21 CFR 862.1660, within the Clinical Chemistry review panel as a Class I device.