The following data is part of a premarket notification filed by Horiba Abx with the FDA for Abx Pentra Dx 120: Option Sps Evolution.
| Device ID | K050719 |
| 510k Number | K050719 |
| Device Name: | ABX PENTRA DX 120: OPTION SPS EVOLUTION |
| Classification | Counter, Differential Cell |
| Applicant | HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE Montpellier, Herault, FR 34184 |
| Contact | Tim Lawton |
| Correspondent | Tim Lawton HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE Montpellier, Herault, FR 34184 |
| Product Code | GKZ |
| Subsequent Product Code | GKJ |
| Subsequent Product Code | KPA |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-21 |
| Decision Date | 2005-04-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03610230006375 | K050719 | 000 |
| 03610230006368 | K050719 | 000 |
| 03610230006290 | K050719 | 000 |
| 03610230006283 | K050719 | 000 |
| 03610230005989 | K050719 | 000 |
| 03610230005972 | K050719 | 000 |
| 03610230005965 | K050719 | 000 |
| 03610230006498 | K050719 | 000 |
| 03610230006481 | K050719 | 000 |