The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Facsprep Robotic Sample Preparation System.
| Device ID | K904795 |
| 510k Number | K904795 |
| Device Name: | FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM |
| Classification | Apparatus, Automated Blood Cell Diluting |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Contact | Russell Arnsberger |
| Correspondent | Russell Arnsberger BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Product Code | GKH |
| CFR Regulation Number | 864.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-19 |
| Decision Date | 1990-12-31 |