The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Facspresto System, Bd Facspresto Cd4/hb Cartridge, Bd Facspresto Cd4/hb Cartridge Kit.
| Device ID | K150815 |
| 510k Number | K150815 |
| Device Name: | BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge Kit |
| Classification | Automated Multicolor Fluorescent Imaging Cytometric Analysis System |
| Applicant | Becton, Dickinson And Company 2350 Qume Dr. San Jose, CA 95131 |
| Contact | Catherine(katie) Bessette |
| Correspondent | Catherine(katie) Bessette Becton, Dickinson And Company 2350 Qume Dr. San Jose, CA 95131 |
| Product Code | PMG |
| Subsequent Product Code | GKL |
| Subsequent Product Code | JPK |
| Subsequent Product Code | OYE |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-27 |
| Decision Date | 2015-12-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382906607478 | K150815 | 000 |
| 00382906607461 | K150815 | 000 |
| 00382906607454 | K150815 | 000 |