The following data is part of a premarket notification filed by Abx Diagnostics with the FDA for Abx Pentra 120 Retic Automated Hematology Analyzer.
| Device ID | K991839 |
| 510k Number | K991839 |
| Device Name: | ABX PENTRA 120 RETIC AUTOMATED HEMATOLOGY ANALYZER |
| Classification | Counter, Differential Cell |
| Applicant | ABX DIAGNOSTICS 7777 CENTER AVE. SUITE 102 Huntington Beach, CA 92647 |
| Contact | Pat Amtower |
| Correspondent | Pat Amtower ABX DIAGNOSTICS 7777 CENTER AVE. SUITE 102 Huntington Beach, CA 92647 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-28 |
| Decision Date | 1999-08-11 |
| Summary: | summary |