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 And 4-3-3 Optical Configurations), Bd Facsuite Clinical Software, Bd Multitest 6-color Assays, Bd Multitest 4-color Assays, Bd Multitest 6-color Tbnk.
| Device ID | K170974 |
| 510k Number | K170974 |
| Device Name: | BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 And 4-3-3 Optical Configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNK |
| Classification | Flow Cytometric Reagents And Accessories. |
| Applicant | Becton, Dickinson And Company 2350 Qume Dr. San Jose, CA 95131 |
| Contact | Li Zhou |
| Correspondent | Li Zhou 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 | 2017-04-03 |
| Decision Date | 2017-07-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382906630070 | K170974 | 000 |
| 00382906642363 | K170974 | 000 |
| 00382906642370 | K170974 | 000 |
| 00382903405008 | K170974 | 000 |
| 00382906642356 | K170974 | 000 |
| 00382906628756 | K170974 | 000 |
| 00382906628763 | K170974 | 000 |
| 00382906628770 | K170974 | 000 |
| 00382906628787 | K170974 | 000 |
| 00382906628794 | K170974 | 000 |
| 00382906629616 | K170974 | 000 |
| 00382906630032 | K170974 | 000 |
| 00382906630056 | K170974 | 000 |
| 00382906629654 | K170974 | 000 |