The following data is part of a premarket notification filed by Horiba Abx Sas with the FDA for Abx Pentra Micro Alb Control L/h.
| Device ID | K133676 |
| 510k Number | K133676 |
| Device Name: | ABX PENTRA MICRO ALB CONTROL L/H |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | HORIBA ABX SAS PARC EUROMEDECINE RUE DU CADUCEE Montpellier, FR 34184 |
| Contact | Caroline Ferrer |
| Correspondent | Caroline Ferrer HORIBA ABX SAS PARC EUROMEDECINE RUE DU CADUCEE Montpellier, FR 34184 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-29 |
| Decision Date | 2014-07-11 |
| Summary: | summary |