K813033 is an FDA 510(k) clearance for the CLAY ADAMS QBC CENTRIFUGAL HEMOTOLOGY. 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 April 9, 1982, 163 days after receiving the submission on October 28, 1981.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.6400.
| 510(k) Number | K813033 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 1981 |
| Decision Date | April 09, 1982 |
| Days to Decision | 163 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 |