The following data is part of a premarket notification filed by Abx Diagnostics with the FDA for Pentra 120/pentra 120 Retic Options Sps, Model Pentra 120.
| Device ID | K022200 |
| 510k Number | K022200 |
| Device Name: | PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120 |
| Classification | Counter, Differential Cell |
| Applicant | ABX DIAGNOSTICS PARC EUROMEDECINE RUE DU CADUCEE Monpellier, FR 34184 |
| Contact | Tim Lawton |
| Correspondent | Tim Lawton ABX DIAGNOSTICS PARC EUROMEDECINE RUE DU CADUCEE Monpellier, FR 34184 |
| Product Code | GKZ |
| Subsequent Product Code | GKJ |
| Subsequent Product Code | KPA |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-05 |
| Decision Date | 2002-07-29 |
| Summary: | summary |