The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Ematology Diluent Reservoir Closure.
| Device ID | K770980 |
| 510k Number | K770980 |
| Device Name: | EMATOLOGY DILUENT RESERVOIR CLOSURE |
| Classification | Hemocytometer |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1875 EYE ST. NW STE. 625 Washington, DC 20006 |
| Product Code | GHO |
| CFR Regulation Number | 864.6160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-05-31 |
| Decision Date | 1977-07-11 |