The following data is part of a premarket notification filed by Horiba Abx Sas with the FDA for Abx Micros Es 60 Ot And Abx Micros Es 60 Ct.
| Device ID | K170353 |
| 510k Number | K170353 |
| Device Name: | ABX MICROS ES 60 OT And ABX MICROS ES 60 CT |
| 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 | 2017-02-03 |
| Decision Date | 2017-11-01 |
| Summary: | summary |