K071779 is an FDA 510(k) clearance for the ABX PENTRA URINE CAL. This device is classified as a Calibrator, Multi-analyte Mixture (Class II - Special Controls, product code JIX).
Submitted by Horiba Abx (Montpellier, FR). The FDA issued a Cleared decision on March 5, 2008, 247 days after receiving the submission on July 2, 2007.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K071779 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 2007 |
| Decision Date | March 05, 2008 |
| Days to Decision | 247 days |
| Submission Type | Abbreviated |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JIX — Calibrator, Multi-analyte Mixture |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1150 |