The following data is part of a premarket notification filed by Horiba Abx with the FDA for Abx Pentra Urine Cal.
| Device ID | K071779 |
| 510k Number | K071779 |
| Device Name: | ABX PENTRA URINE CAL |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE, BP 7290 Montpellier, FR 34184 |
| Contact | Olivier Ducamp |
| Correspondent | Olivier Ducamp HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE, BP 7290 Montpellier, FR 34184 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-02 |
| Decision Date | 2008-03-05 |
| Summary: | summary |