510(k) K110530
ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL by
HORIBA ABX SAS
— Product Code CGX
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 30, 2012
- Date Received
- February 24, 2011
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Alkaline Picrate, Colorimetry, Creatinine
- Device Class
- Class II
- Regulation Number
- 862.1225
- Review Panel
- CH
- Submission Type