The following data is part of a premarket notification filed by Abx, Inc. with the FDA for Vega Hematology Analyzer.
| Device ID | K962633 |
| 510k Number | K962633 |
| Device Name: | VEGA HEMATOLOGY ANALYZER |
| Classification | Counter, Differential Cell |
| Applicant | ABX, INC. RUE DU CADUCEE-BP7290 Montpellier Cedex 4, FR 34184 |
| Contact | Brice Prouve |
| Correspondent | Brice Prouve ABX, INC. RUE DU CADUCEE-BP7290 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 | 1996-07-05 |
| Decision Date | 1996-11-04 |
| Summary: | summary |