The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Facslyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 And 4-3-5 Optical Configurations), Bd Facsduet Sample Preparation System, Bd Facs Universal Loader, Bd Facsuite Clinical Software, Bd Multitest 6-color Assay Modules, Bd Multitest 4-color Assay Modu.
| Device ID | K201814 |
| 510k Number | K201814 |
| Device Name: | BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 And 4-3-5 Optical Configurations), BD FACSDuet Sample Preparation System, BD FACS Universal Loader, BD FACSuite Clinical Software, BD Multitest 6-Color Assay Modules, BD Multitest 4-Color Assay Modu |
| Classification | Flow Cytometric Reagents And Accessories. |
| Applicant | Becton, Dickinson And Company 2350 Qume Dr. San Jose, CA 95131 |
| Contact | Niya Su |
| Correspondent | Niya Su Becton, Dickinson And Company 2350 Qume Dr. San Jose, CA 95131 |
| Product Code | OYE |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-01 |
| Decision Date | 2020-09-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382906631282 | K201814 | 000 |
| 00382906635181 | K201814 | 000 |