The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Icrotaineo Brand Tube.
| Device ID | K771370 |
| 510k Number | K771370 |
| Device Name: | ICROTAINEO BRAND TUBE |
| Classification | Tray, Blood Collection |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1875 EYE ST. NW STE. 625 Washington, DC 20006 |
| Product Code | GJE |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-07-25 |
| Decision Date | 1977-08-03 |