The following data is part of a premarket notification filed by Horiba Abx Sas with the FDA for Pentra Xlr.
| Device ID | K151133 |
| 510k Number | K151133 |
| Device Name: | PENTRA XLR |
| Classification | Counter, Differential Cell |
| Applicant | HORIBA ABX SAS PARC EUROMEDECINE RUE DU CADUCEE, BP 7290 Montpellier Cedex 4, FR 34184 |
| Contact | Caroline Ferrer |
| Correspondent | Caroline Ferrer HORIBA ABX SAS PARC EUROMEDECINE RUE DU CADUCEE, BP 7290 Montpellier Cedex 4, FR 34184 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-28 |
| Decision Date | 2015-12-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03610230006405 | K151133 | 000 |