K123171 is an FDA 510(k) clearance for the ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT. This device is classified as a Azo Dye, Calcium (Class II - Special Controls, product code CJY).
Submitted by HORIBA ABX SAS (Montpellier, FR). The FDA issued a Cleared decision on July 3, 2013, 267 days after receiving the submission on October 9, 2012.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1145.
| 510(k) Number | K123171 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 09, 2012 |
| Decision Date | July 03, 2013 |
| Days to Decision | 267 days |
| Submission Type | Abbreviated |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CJY - Azo Dye, Calcium |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1145 |