The following data is part of a premarket notification filed by Becton Dickinson & Co. with the FDA for Modification To Bd Facscanto System With Bd Facscanto Clinical Software.
| Device ID | K050191 |
| 510k Number | K050191 |
| Device Name: | MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE |
| Classification | Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis |
| Applicant | BECTON DICKINSON & CO. 2350 Qume Drive San Jose, CA 95131 |
| Contact | Carter Navarro |
| Correspondent | Carter Navarro BECTON DICKINSON & CO. 2350 Qume Drive San Jose, CA 95131 |
| Product Code | PER |
| CFR Regulation Number | 862.2750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-27 |
| Decision Date | 2005-02-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382906641229 | K050191 | 000 |
| 00382906641199 | K050191 | 000 |
| 00382906641144 | K050191 | 000 |