The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Qbc Hemacan Hematology System.
| Device ID | K923121 |
| 510k Number | K923121 |
| Device Name: | QBC HEMACAN HEMATOLOGY SYSTEM |
| Classification | Counter, Cell, Automated (particle Counter) |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Contact | Don A Cutshall |
| Correspondent | Don A Cutshall BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Product Code | GKL |
| CFR Regulation Number | 864.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-26 |
| Decision Date | 1992-09-22 |