K911731 is an FDA 510(k) clearance for the LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITR. This device is classified as a Lymphocyte Separation Medium (Class I - General Controls, product code JCF).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on December 15, 1992, 608 days after receiving the submission on April 17, 1991.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.8500.
| 510(k) Number | K911731 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 17, 1991 |
| Decision Date | December 15, 1992 |
| Days to Decision | 608 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | JCF — Lymphocyte Separation Medium |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.8500 |