Clearance Summary
ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL received FDA 510(k) clearance under submission number K110530, 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 2012-04-30.
- Submission: K110530
- Applicant / Sponsor: HORIBA ABX SAS
- Clearance pathway: Abbreviated
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1225
- Decision date: 2012-04-30
Classification & Regulation
This clearance is catalogued under FDA product code CGX and 21 CFR 862.1225, within the Clinical Chemistry review panel as a Class II device.