K843062 is an FDA 510(k) clearance for the TBM-REAGENT FOR T,B CELL & MONOCYTES. 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 April 3, 1985, 243 days after receiving the submission on August 3, 1984.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 864.5220.
| 510(k) Number | K843062 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 03, 1984 |
| Decision Date | April 03, 1985 |
| Days to Decision | 243 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | LIZ — Assay, T Lymphocyte Surface Marker |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5220 |