The following data is part of a premarket notification filed by Becton Dickinson Immunocytometry Systems with the FDA for Facsort Flow Cytometer.
| Device ID | K923790 |
| 510k Number | K923790 |
| Device Name: | FACSORT FLOW CYTOMETER |
| Classification | Counter, Differential Cell |
| Applicant | BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS 2350 QUME DR. San Jose, CA 95131 -1807 |
| Contact | Anna Longwell |
| Correspondent | Anna Longwell BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS 2350 QUME DR. 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 | 1992-07-28 |
| Decision Date | 1993-09-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382903431786 | K923790 | 000 |
| 00382903431168 | K923790 | 000 |
| 00382903429769 | K923790 | 000 |
| 00382903429752 | K923790 | 000 |
| 00382903429745 | K923790 | 000 |
| 00382903429738 | K923790 | 000 |