The following data is part of a premarket notification filed by Abx Diagnostics with the FDA for Abx Pentra 60c+ Hematology Analyzer.
| Device ID | K003677 |
| 510k Number | K003677 |
| Device Name: | ABX PENTRA 60C+ HEMATOLOGY ANALYZER |
| Classification | Counter, Differential Cell |
| Applicant | ABX DIAGNOSTICS 34 BUNSEN DR. Irvine, CA 92618 -4210 |
| Contact | Bruce H Davis |
| Correspondent | Bruce H Davis ABX DIAGNOSTICS 34 BUNSEN DR. Irvine, CA 92618 -4210 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-29 |
| Decision Date | 2000-12-26 |