K854093 is an FDA 510(k) clearance for the LEUCO PREP. This device is classified as a Lymphocyte Separation Medium (Class I - General Controls, product code JCF).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Paramus, US). The FDA issued a Cleared decision on November 12, 1985, 36 days after receiving the submission on October 7, 1985.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.8500.
| 510(k) Number | K854093 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 07, 1985 |
| Decision Date | November 12, 1985 |
| Days to Decision | 36 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 |