K770385 is an FDA 510(k) clearance for the LATELET DETERMIN. KIT, CAT NO. 2521. This device is classified as a Counter, Cell, Automated (particle Counter) (Class II - Special Controls, product code GKL).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on April 8, 1977, 39 days after receiving the submission on February 28, 1977.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5200.
| 510(k) Number | K770385 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 28, 1977 |
| Decision Date | April 08, 1977 |
| Days to Decision | 39 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | GKL — Counter, Cell, Automated (particle Counter) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5200 |