The following data is part of a premarket notification filed by Abx Diagnostics with the FDA for Abx Micros 60 Hematology Analyzer.
| Device ID | K014203 |
| 510k Number | K014203 |
| Device Name: | ABX MICROS 60 HEMATOLOGY ANALYZER |
| Classification | Instrument, Automated Platelet Counting |
| Applicant | ABX DIAGNOSTICS 34 BUNSEN DR. Irvine, CA 92618 -4210 |
| Contact | Tom M Phillips |
| Correspondent | Tom M Phillips ABX DIAGNOSTICS 34 BUNSEN DR. Irvine, CA 92618 -4210 |
| Product Code | GKX |
| CFR Regulation Number | 864.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-21 |
| Decision Date | 2002-02-28 |
| Summary: | summary |