K771370 is an FDA 510(k) clearance for the ICROTAINEO BRAND TUBE. This device is classified as a Tray, Blood Collection (Class II - Special Controls, product code GJE).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on August 3, 1977, 9 days after receiving the submission on July 25, 1977.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 862.1675.
| 510(k) Number | K771370 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 25, 1977 |
| Decision Date | August 03, 1977 |
| Days to Decision | 9 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | GJE — Tray, Blood Collection |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1675 |