K851639 is an FDA 510(k) clearance for the ANTI-LEU-12 B CELL REAGENT. This device is classified as a Assay, B Lymphocyte Marker (Class II - Special Controls, product code LJD).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on July 2, 1986, 439 days after receiving the submission on April 19, 1985.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5220.
| 510(k) Number | K851639 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 19, 1985 |
| Decision Date | July 02, 1986 |
| Days to Decision | 439 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | LJD — Assay, B Lymphocyte Marker |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5220 |