The following data is part of a premarket notification filed by Horiba Abx Sas with the FDA for Abx Pentra Tpu Cal, Model A11a01898.
| Device ID | K092570 |
| 510k Number | K092570 |
| Device Name: | ABX PENTRA TPU CAL, MODEL A11A01898 |
| Classification | Calibrator, Secondary |
| Applicant | HORIBA ABX SAS PARC EUROMEDECINE RUE DU CADUCEE, BP 7290 Montpellier, FR 34184 |
| Contact | Caroline Ferrer |
| Correspondent | Caroline Ferrer HORIBA ABX SAS PARC EUROMEDECINE RUE DU CADUCEE, BP 7290 Montpellier, FR 34184 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-21 |
| Decision Date | 2009-10-16 |
| Summary: | summary |