The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Qbc Centrifugal Hematology System.
| Device ID | K821803 |
| 510k Number | K821803 |
| Device Name: | QBC CENTRIFUGAL HEMATOLOGY SYSTEM |
| Classification | Centrifuge, Hematocrit |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1875 EYE ST. NW STE. 625 Washington, DC 20006 |
| Product Code | GKG |
| CFR Regulation Number | 864.6400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-16 |
| Decision Date | 1982-09-14 |