The following data is part of a premarket notification filed by Becton Dickinson & Co. with the FDA for Bd Facs Sample Prep Assistant Iii (spa Iii).
| Device ID | K102064 |
| 510k Number | K102064 |
| Device Name: | BD FACS SAMPLE PREP ASSISTANT III (SPA III) |
| Classification | Counter, Differential Cell |
| Applicant | BECTON DICKINSON & CO. 2350 QUME DRIVE San Jose, CA 95131 -1807 |
| Contact | Katy Campbell |
| Correspondent | Katy Campbell BECTON DICKINSON & CO. 2350 QUME DRIVE San Jose, CA 95131 -1807 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-23 |
| Decision Date | 2011-03-07 |
| Summary: | summary |