K110530 is an FDA 510(k) clearance for the ABX PENTRA CREATININE 120 CP. This device is classified as a Alkaline Picrate, Colorimetry, Creatinine (Class II - Special Controls, product code CGX).
Submitted by HORIBA ABX SAS (Montpellier, FR). The FDA issued a Cleared decision on April 30, 2012, 431 days after receiving the submission on February 24, 2011.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1225.
| 510(k) Number | K110530 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 24, 2011 |
| Decision Date | April 30, 2012 |
| Days to Decision | 431 days |
| Submission Type | Abbreviated |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CGX - Alkaline Picrate, Colorimetry, Creatinine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1225 |