The following data is part of a premarket notification filed by Bd Biosciences with the FDA for Bd Facscanto With Bd Facsanto Software.
| Device ID | K041074 |
| 510k Number | K041074 |
| Device Name: | BD FACSCANTO WITH BD FACSANTO SOFTWARE |
| Classification | Counter, Differential Cell |
| Applicant | BD Biosciences 2350 QUME DR. San Jose, CA 95131 -1807 |
| Contact | Kim Fonda |
| Correspondent | Kim Fonda BD Biosciences 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 | 2004-04-26 |
| Decision Date | 2004-09-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382906577702 | K041074 | 000 |
| 00382906577665 | K041074 | 000 |
| 00382906570819 | K041074 | 000 |
| 00382906466020 | K041074 | 000 |
| 00382906466006 | K041074 | 000 |
| 00382903383139 | K041074 | 000 |