The following data is part of a premarket notification filed by Abx Diagnostics with the FDA for Abx Pentra 60 Hematology Analyzer.
| Device ID | K992511 |
| 510k Number | K992511 |
| Device Name: | ABX PENTRA 60 HEMATOLOGY ANALYZER |
| Classification | Counter, Differential Cell |
| Applicant | ABX DIAGNOSTICS 34 BUNSEN DR. Irvine, CA 92618 -4210 |
| Contact | Pat Amtower |
| Correspondent | Pat Amtower ABX DIAGNOSTICS 34 BUNSEN DR. Irvine, CA 92618 -4210 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-27 |
| Decision Date | 1999-10-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590578787 | K992511 | 000 |
| 15099590576462 | K992511 | 000 |