The following data is part of a premarket notification filed by Becton Dickinson Immunocytometry Systems with the FDA for Bd Facs 7-color Setup Beads.
| Device ID | K040026 |
| 510k Number | K040026 |
| Device Name: | BD FACS 7-COLOR SETUP BEADS |
| Classification | Counter, Differential Cell |
| Applicant | BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS 2350 QUME DR. San Jose, CA 95131 -1807 |
| Contact | Cindy Morrow |
| Correspondent | Cindy Morrow 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 | 2004-01-07 |
| Decision Date | 2004-09-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382903357758 | K040026 | 000 |