K821803 is an FDA 510(k) clearance for the QBC CENTRIFUGAL HEMATOLOGY SYSTEM. This device is classified as a Centrifuge, Hematocrit (Class II - Special Controls, product code GKG).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on September 14, 1982, 90 days after receiving the submission on June 16, 1982.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.6400.
| 510(k) Number | K821803 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 16, 1982 |
| Decision Date | September 14, 1982 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | GKG — Centrifuge, Hematocrit |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.6400 |