The following data is part of a premarket notification filed by Becton Dickinson Monoclonal Center with the FDA for Facscomp Software & Calibrite 3 Color Beads Kit/calibrite Percp Beads.
| Device ID | K961623 |
| 510k Number | K961623 |
| Device Name: | FACSCOMP SOFTWARE & CALIBRITE 3 COLOR BEADS KIT/CALIBRITE PERCP BEADS |
| Classification | Counter, Differential Cell |
| Applicant | BECTON DICKINSON MONOCLONAL CENTER 2350 Qume Dr. San Jose, CA 95131 |
| Contact | Anna Longwell |
| Correspondent | Anna Longwell BECTON DICKINSON MONOCLONAL CENTER 2350 Qume Dr. San Jose, CA 95131 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-26 |
| Decision Date | 1996-06-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382903495023 | K961623 | 000 |
| 00382903404971 | K961623 | 000 |
| 00382903404865 | K961623 | 000 |