K842218 is an FDA 510(k) clearance for the ANTI-LEU-4 FITC LYSIN C BUFFER. This device is classified as a Assay, T Lymphocyte Surface Marker (Class II - Special Controls, product code LIZ).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on December 27, 1984, 206 days after receiving the submission on June 4, 1984.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5220.
| 510(k) Number | K842218 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 04, 1984 |
| Decision Date | December 27, 1984 |
| Days to Decision | 206 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | LIZ — Assay, T Lymphocyte Surface Marker |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5220 |