K811591 is an FDA 510(k) clearance for the B-D DRAKE WILLOCK #7000 SERIES ULTRAF. This device is classified as a System, Dialysate Delivery, Single Patient (Class II - Special Controls, product code FKP).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Walker, US). The FDA issued a Cleared decision on July 10, 1981, 32 days after receiving the submission on June 8, 1981.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K811591 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 08, 1981 |
| Decision Date | July 10, 1981 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | FKP — System, Dialysate Delivery, Single Patient |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |