The following data is part of a premarket notification filed by Abx Diagnostics with the FDA for Pentra 80.
| Device ID | K024002 |
| 510k Number | K024002 |
| Device Name: | PENTRA 80 |
| 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 |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-04 |
| Decision Date | 2003-01-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03610230006399 | K024002 | 000 |
| 03610230005996 | K024002 | 000 |